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| ID | Type | Description | Link |
|---|---|---|---|
| U01NS050573 | U.S. NIH Grant/Contract | View source |
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The investigational drug is unlikely to demonstrate efficacy over placebo for this indication. However, no safety issues were discovered.
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| University of Rochester | OTHER |
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The purpose of this study is to evaluate the safety and effectiveness of high dosages of Coenzyme Q10 in slowing clinical decline in people who have early Parkinson disease.
Parkinson disease (PD) is a progressive neurodegenerative disease that affects more than 1,000,000 Americans. Currently there is no proven therapy to reduce the rate of progression of PD. In a previous phase II clinical trial, investigators demonstrated that Coenzyme Q10 (CoQ) at dosages of 300, 600, and 1200 mg/day was safe and well-tolerated in individuals with early, untreated PD. The findings also suggested that CoQ may slow the progressive impairment of PD as measured by the Unified Parkinson Disease Rating Scale (UPDRS).
In this study, researchers will conduct a randomized, placebo-controlled, phase III trial of CoQ to confirm and extend the results of the earlier phase II study. The primary objective of this trial is to compare the effect of two dosages of CoQ (1200 and 2400 mg/day) and placebo on the total UPDRS score in people with early PD. The study also will evaluate independent function, cognition, and quality of life. Plasma CoQ levels will be measured at months 1, 8 and 16 and correlated with changes in UPDRS scores.
Participants will be randomly assigned to receive a placebo (an inactive substance), 1200 mg/d CoQ, or 2400 mg/d CoQ. They will be evaluated at screening, baseline, and during visits at months 1, 4, 8, 12, and 16. Information gained from this trial could lead to changes in management of people with early PD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day) |
|
| B | Experimental | Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day) |
|
| C | Placebo Comparator | Placebo (with vitamin E 1200 IU/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coenzyme Q10 with vitamin E | Drug | 2400 mg dose - eight 300 mg Coenzyme Q10 chewable wafers taken orally four times a day; 1200 mg dose - four 300 mg Coenzyme Q10 and four placebo chewable wafers taken orally four times a day. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Total Score (Sum of Parts I, II and III Ranges From 0 to 176)) | Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline visit and month 16 or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first. The UPDRS score has three components, each consisting of questions answered on a 0-4 point scale. Part I assesses mentation, behavior and mood; Part II assesses activities of daily living in the week prior to the designated visit; and Part III assesses motor abilities at the time of the visit. A total of 31 items are included in Parts I, II and III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total score ranges from 0-176. | Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Modified Schwab & England Independence Scale From Baseline to 16 Months | This scale measures activities of daily living. This is an investigator and subject assessment of the subject's level of independence at all scheduled visits. The subject is scored on a percentage scale reflective of his/her ability to perform acts of daily living in relation to pre-Parkinson disease ability. Scores range in increments of 10%: 100% for normal (subject is completely independent; essentially normal) to 0% (vegetative functions such as swallowing, bladder and bowel functions are not functioning; bedridden). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M. Flint Beal, MD | Weill Medical College of Cornell University, New York Hospital Department of Neurology | Principal Investigator |
| David Oakes, PhD | University of Rochester, Department of Biostatistics | Principal Investigator |
| Ira Shoulson, MD | University of Rochester, Clinical Trials Coordination Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama, Birmingham, 350 Sparks Center, 1720 7Th Avenue South | Birmingham | Alabama | 35233 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7998775 | Background | Beal MF, Henshaw DR, Jenkins BG, Rosen BR, Schulz JB. Coenzyme Q10 and nicotinamide block striatal lesions produced by the mitochondrial toxin malonate. Ann Neurol. 1994 Dec;36(6):882-8. doi: 10.1002/ana.410360613. | |
| 9479058 | Background | Beal MF, Matthews RT, Tieleman A, Shults CW. Coenzyme Q10 attenuates the 1-methyl-4-phenyl-1,2,3,tetrahydropyridine (MPTP) induced loss of striatal dopamine and dopaminergic axons in aged mice. Brain Res. 1998 Feb 2;783(1):109-14. doi: 10.1016/s0006-8993(97)01192-x. |
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Patients were required to undergo a thorough screening visit. If patients were taking CoEnzyme Q10 but otherwise eligible for assignment, they were asked to return after a wash out period of 60 to 120 days based on daily dosage.
The recruitment period for the required 600 patients was from January 2009 to October 2010. There were 67 sites (60 in the US and 7 in Canada) that participated in the study. Most of these sites were located at or affiliated with large academic medical centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day | Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day) |
| FG001 | B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| placebo with vitamin E | Drug | placebo or an inactive substance (with vitamin E 1200 IU/day); Placebo - eight chewable wafers taken orally four times a day. |
|
| Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first |
| Change in Modified Rankin Scale From Baseline to 16 Months | The Modified Rankin Scale is a global functional health index with a strong accent on physical disability. Subjects are scored on a scale of 0 (no symptoms at all) to 5 (severe disability: bedridden incontinent, and requiring constant nursing care and attention. | Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first |
| Change in PD Quality of Life Scale From Baseline to 16 Months | The subject will complete a questionnaire that will evaluate how Parkinson disease has affected their health and overall quality of life at each visit. The total quality of life scale measures a total of 33 aspects of quality of life. Each aspect is rated on scale of 0 (best outcome) to 4 (worst outcome). Total score range is 0-132. A higher score or increased score compared to a previous visit indicates a lowered quality of life. | Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first |
| Change in Symbol Digit Modalities Test From Baseline to 16 Months | The Symbol Digit Modalities Test screens cognitive impairment by using a simple substitution tasks that individuals with normal functioning can easily perform. The test score range is from 0(worst outcome) to 110 (best outcome). | Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first |
| Change in Hoehn & Yahr Score From Baseline to 16 Months | The Modified Hoehn and Yahr Scale is an 8-level Parkinson disease staging instrument. The investigator will assess disease stage at each level. The disease stages range from the best outcome of 0 (no signs of disease) to the worst outcome of 5 (wheelchair bound or bedridden unless aided). | Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first |
| CoQ10 Levels in Plasma | Based on samples analyzed to date | Baseline, 1, 8 and 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first |
| Adverse Experiences: Back Pain | Number of participants with back pain | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
| Adverse Experiences: Constipation | Number of participants with constipation | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
| Adverse Experiences: Insomnia | Number of participants with insomnia | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
| Adverse Experiences: Anxiety | Number of participants with anxiety | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
| Adverse Experiences: Tremor | Number of participants with tremor | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
| Adverse Experiences: Nasopharyngitis | Number of participants with nasopharyngitis | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
| Adverse Experiences: Diarrhoea | Number of participants with diarrhoea | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
| Adverse Experiences: Headache | Number of participants with headache | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
| Adverse Experiences: Urinary Tract Infection | Number of patients with urinary tract infections | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
| Adverse Experiences: Nausea | Number of participants with nausea | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
| Adverse Experiences: Hypertension | Number of participants with hypertension | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
| Adverse Experiences: Depression | Number of participants with depression | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
| Adverse Experiences: Constipation: Moderate/Severe | Number of participants with moderate/severe constipation | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
| Adverse Experiences: Anxiety: Moderate/Severe | Number of participants with moderate/severe anxiety | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
| Adverse Experiences: Back Pain: Moderate/Severe | Number of participants with moderate/severe back pain | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
| Adverse Experiences: Insomnia: Moderate/Severe | Number of participants with moderate/severe insomnia | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
| Barrow Neurological Clinics At St Joseph'S Hospital & Medical Center, 500 West Thomas Road Suite 720 |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Mayo Clinic Arizona, 13400 East Shea Boulevard, Desk 34 3B | Scottsdale | Arizona | 85260 | United States |
| Sunhealth Research Institute, 10515 West Santa Fe Drive | Sun City | Arizona | 85351 | United States |
| The Parkinson'S & Movement Disorder Institute, 9940 Talbert Avenue, Suite 204 | Fountain Valley | California | 92708 | United States |
| University of California Irvine, 100 Irvine Hall | Irvine | California | 92697-4275 | United States |
| University of California San Diego, Alzheimer'S Disease Research Center, 9500 Gilman Drive | La Jolla | California | 92093-0948 | United States |
| UCLA Medical Center, 710 Westwood Plaza, A-253 | Los Angeles | California | 900095 | United States |
| UC Davis Dept of Neurology, 4860 Y Street, Suite 3700 | Sacramento | California | 95817 | United States |
| The Parkinson's Institute, 675 ALMANOR AVENUE | Sunnyvale | California | 94085 | United States |
| Department of Neurology/Mail Stop B185, 12631 East 17Th Avenue Room 5209, Academic Office 1 Po Box 6511 | Aurora | Colorado | 80045 | United States |
| Colorado Neurological Institute, 701 East Hampden Avenue, Suite 510 | Littleton | Colorado | 80113 | United States |
| The Institute For Neurodegenerative Disorders, 60 Temple Street, Suite 8B | New Haven | Connecticut | 06510 | United States |
| University of Florida, McKnight Brain Institute Po Box 100236, 100 S Newell Drive L3-100 | Gainsville | Florida | 32610-5806 | United States |
| University of Miami, 1501 North West 9Th Avenue Second Floor, Department of Neurology D4-5 | Miami | Florida | 33136 | United States |
| University of South Florida, 4 Columbia Drive, Suite 410 | Tampa | Florida | 33606 | United States |
| Emory University School of Medicine, Wesley Woods Health Center, 1841 Clifton Road NE Room 328 | Atlanta | Georgia | 30329 | United States |
| Movement Disorders Program, Department of Neurology, Medical College of Georgia | Augusta | Georgia | 30912 | United States |
| Northwestern University, 710 North Lake Shore Drive | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center Department of Neurological Sciences, 1725 West Harrison Suite 755 | Chicago | Illinois | 60612 | United States |
| University of Chicago, 5841 South Maryland Avenue, Mc2030 | Chicago | Illinois | 60637 | United States |
| Indiana University School of Medicine, Outpatient Clinical Research Facility, 535 Barnhill Drive Room #150 | Indianapolis | Indiana | 46202 | United States |
| University of Iowa Hospitals, 2133 Rcp Department of Neurology, 200 Hawkins Drive | Iowa City | Iowa | 52242 | United States |
| The University of Kansas Medical Center, Department of Neurology Ms #2012, 3599 Rainbow Boulevard | Kansas City | Kansas | 66160 | United States |
| University of Louisville, Movement Disorder Clinic, Frazier Rehab, 220 Abraham Flexner, Suite 606 | Louisville | Kentucky | 40202 | United States |
| Ochsner Clinic Foundation, 1514 Jefferson Highway, Dept of Neurology 7Th Floor | New Orleans | Louisiana | 70121 | United States |
| Lsuhsc Shreveport, Department of Neurology, 1501 Kings Highway Room 3-436 | Shreveport | Louisiana | 71103 | United States |
| University of Maryland School of Medicine, 22 South Greene Street, N4 W49-B | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins, 601 North Caroline Street, Suite 5064 | Baltimore | Maryland | 21287-0875 | United States |
| Parkinson & Movement Dis Center If Maryland, 8180 Lark Brown Road, Suite 101 | Elkridge | Maryland | 21075 | United States |
| Boston University Medical Center, Department of Neurology, 715 Albany Street C329 | Boston | Massachusetts | 02118 | United States |
| Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Shapiro 809D | Boston | Massachusetts | 02215 | United States |
| University of Minnesota, 420 Delaware Street SE, Mmc 295 | Minneapolis | Minnesota | 55455 | United States |
| Washington University School of Medicine, 660 South Euclid, Box 8111 | St Louis | Missouri | 63110-1093 | United States |
| Albany Medical College, Parkinson'S Disease & Movement Disorders Ctr, 47 New Scottland Avenue | Albany | New York | 12208 | United States |
| Suny Downstate Medical Center , 450 Clarkson Avenue , Box 1213 | Brooklyn | New York | 11203 | United States |
| Northshore-Lij Health System, the Feinstein Institute Fpr Medical Research, 350 Community Drive Room 100 | Manhasset | New York | 11030 | United States |
| Beth Israel Medical Center, 10 Union Square East, Suite 5Hh2 | New York | New York | 10003 | United States |
| Beth Israel Medical Center, Phillips Ambulatory Care Center, 10 Union Square East Room 5Ho1 | New York | New York | 10003 | United States |
| Parkinson'S Dis & Movement Disorders Inst, 428 East 72Nd Street, Suite 400 | New York | New York | 10021 | United States |
| Weill Medical College of Cornell | New York | New York | 10021 | United States |
| Columbia University, 710 West 168Th Street, 3Rd Floor | New York | New York | 10032 | United States |
| University of Rochester Department of Neurology, 919 Westfall Road Building C Suite 220 | Rochester | New York | 14618 | United States |
| JACOBI MEDICAL CENTER, 1400 Pelham Pkwy S | The Bronx | New York | 10461 | United States |
| Duke University Medical Center, Duke Health Center At Morreene Road, 932 Morreene Road Room 213 | Durham | North Carolina | 27705 | United States |
| University Neurology Inc., 222 Piedmont Avenue, Suite 3200 | Cincinnati | Ohio | 45219 | United States |
| The Cleveland Clinic Foundation, 9500 Euclid Avenue S-31 | Cleveland | Ohio | 44195 | United States |
| Ohio State University Medical Center, 1581 Dodd Drive, 371 McCampbell Hall | Columbus | Ohio | 43210 | United States |
| University of Toledo , 3000 Arlington Avenue , Mail Stop 1195 | Toledo | Ohio | 43614 | United States |
| Oregon Health & Science University, Dept of Neurology, 3181 SW Sam Jackson Park Road Op-32 | Portland | Oregon | 97239-3098 | United States |
| Penn State Milton S Hershey Med Center, Department of Neurology Mc H109 Room 2846, 500 University Drive Po Box 850 | Hershey | Pennsylvania | 17033 | United States |
| University of Pennsylvania, Pennsylvania Hospital Department of Neurology, 330 South 9Th Street | Philadelphia | Pennsylvania | 19107 | United States |
| Neurohealth Parkinson'S Disease, Movement Disorder Center, 227 Centerville Road | Warwick | Rhode Island | 02886 | United States |
| Medical University of South Carolina, Charleston Memorial Hospital, 326 Calhoun Street Suite 308 | Charleston | South Carolina | 29401 | United States |
| Semmes Murphey Clinic, 1211 Union Avenue, Suite 200 | Memphis | Tennessee | 38104 | United States |
| Baylor College of Medicine - Parkinson'S, Disease Center and Movement Disorders Clinic, 65501 Fannin St, Suite 1801 | Houston | Texas | 77030 | United States |
| University of Vermont , Department of Neurology Given Building C-219 , 89 Beaumont Avenue | Burlington | Vermont | 05405 | United States |
| Booth Gardner Parkinson'S Care Center, 13030 121St Way North East Suite 203 | Kirkland | Washington | 98034 | United States |
| Medical College of Wisconsin, Department of Neurology, 9200 West Wisconsin Avenue | Milwaukee | Wisconsin | 53226-0099 | United States |
| Un of Calgary Movement Disorders Program, Dept of Clin Neurosciences Area 3 Neurology, 3350 Hospital Dr NW Health Sciences Centre | Calgary | Alberta | T2N4NI | Canada |
| University of Alberta Glenrose Rehab Hosp, Rm 0601 Glen East, 10230 - 111 Avenue | Edmonton | Alberta | T5G 0B7 | Canada |
| London Health Sciences Centre, University Campus Room 10N29, 339 Windermere Road | London | Ontario | N6A 5A5 | Canada |
| The Ottawa Hospital-Civic Campus, 1053 Carling Avenue C2 Room 2210 | Ottawa | Ontario | K1Y 4E9 | Canada |
| Toronto Western Hospital, Univ Health Network, 399 Bathurst Street Mc 7-402, Movement Disorders Centre | Toronto | Ontario | M5T 2S8 | Canada |
| CHUM-HOPITAL NOTRE DAME, 1560 rue SHERBROOKE est ROOM GR 1185, PAVILLON DECHAMPS etage rez-de-chaussee | Montreal | Quebec | H2L 4M1 | Canada |
| Quebec Memory and Motor Skills Dis Clinic, Price Building 3Rd Floor, 65 Sainte-Anne Street | Québec | Quebec | G1R 3X5 | Canada |
| University of Sherbrooke, 3001 12E Avenue Nord | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Royal University Hospital, 103 Hospital Drive, Room 1663 | Saskatoon | Saskatchewan | S7N OW8 | Canada |
| 10856939 | Background | Beal MF. Energetics in the pathogenesis of neurodegenerative diseases. Trends Neurosci. 2000 Jul;23(7):298-304. doi: 10.1016/s0166-2236(00)01584-8. |
| 12069110 | Background | Beal MF. Coenzyme Q10 as a possible treatment for neurodegenerative diseases. Free Radic Res. 2002 Apr;36(4):455-60. doi: 10.1080/10715760290021315. |
| 17200487 | Background | NINDS NET-PD Investigators. A randomized clinical trial of coenzyme Q10 and GPI-1485 in early Parkinson disease. Neurology. 2007 Jan 2;68(1):20-8. doi: 10.1212/01.wnl.0000250355.28474.8e. |
| 12707423 | Background | Ravina BM, Fagan SC, Hart RG, Hovinga CA, Murphy DD, Dawson TM, Marler JR. Neuroprotective agents for clinical trials in Parkinson's disease: a systematic assessment. Neurology. 2003 Apr 22;60(8):1234-40. doi: 10.1212/01.wnl.0000058760.13152.1a. |
| 12112107 | Background | Shoulson I, Oakes D, Fahn S, Lang A, Langston JW, LeWitt P, Olanow CW, Penney JB, Tanner C, Kieburtz K, Rudolph A; Parkinson Study Group. Impact of sustained deprenyl (selegiline) in levodopa-treated Parkinson's disease: a randomized placebo-controlled extension of the deprenyl and tocopherol antioxidative therapy of parkinsonism trial. Ann Neurol. 2002 May;51(5):604-12. doi: 10.1002/ana.10191. |
| 9266740 | Background | Shults CW, Haas RH, Passov D, Beal MF. Coenzyme Q10 levels correlate with the activities of complexes I and II/III in mitochondria from parkinsonian and nonparkinsonian subjects. Ann Neurol. 1997 Aug;42(2):261-4. doi: 10.1002/ana.410420221. |
| 9521279 | Background | Shults CW, Beal MF, Fontaine D, Nakano K, Haas RH. Absorption, tolerability, and effects on mitochondrial activity of oral coenzyme Q10 in parkinsonian patients. Neurology. 1998 Mar;50(3):793-5. doi: 10.1212/wnl.50.3.793. |
| 12374491 | Background | Shults CW, Oakes D, Kieburtz K, Beal MF, Haas R, Plumb S, Juncos JL, Nutt J, Shoulson I, Carter J, Kompoliti K, Perlmutter JS, Reich S, Stern M, Watts RL, Kurlan R, Molho E, Harrison M, Lew M; Parkinson Study Group. Effects of coenzyme Q10 in early Parkinson disease: evidence of slowing of the functional decline. Arch Neurol. 2002 Oct;59(10):1541-50. doi: 10.1001/archneur.59.10.1541. |
| 12871093 | Background | Shults CW. Coenzyme Q10 in neurodegenerative diseases. Curr Med Chem. 2003 Oct;10(19):1917-21. doi: 10.2174/0929867033456882. |
| 15246848 | Background | Shults CW, Flint Beal M, Song D, Fontaine D. Pilot trial of high dosages of coenzyme Q10 in patients with Parkinson's disease. Exp Neurol. 2004 Aug;188(2):491-4. doi: 10.1016/j.expneurol.2004.05.003. |
| 15998891 | Background | Lee IM, Cook NR, Gaziano JM, Gordon D, Ridker PM, Manson JE, Hennekens CH, Buring JE. Vitamin E in the primary prevention of cardiovascular disease and cancer: the Women's Health Study: a randomized controlled trial. JAMA. 2005 Jul 6;294(1):56-65. doi: 10.1001/jama.294.1.56. |
| 16027460 | Background | Blatt DH, Pryor WA. High-dosage vitamin E supplementation and all-cause mortality. Ann Intern Med. 2005 Jul 19;143(2):150-1; author reply 156-8. doi: 10.7326/0003-4819-143-2-200507190-00018. No abstract available. |
| 15721983 | Background | McDonald SR, Sohal RS, Forster MJ. Concurrent administration of coenzyme Q10 and alpha-tocopherol improves learning in aged mice. Free Radic Biol Med. 2005 Mar 15;38(6):729-36. doi: 10.1016/j.freeradbiomed.2004.11.014. |
| 15537682 | Background | Miller ER 3rd, Pastor-Barriuso R, Dalal D, Riemersma RA, Appel LJ, Guallar E. Meta-analysis: high-dosage vitamin E supplementation may increase all-cause mortality. Ann Intern Med. 2005 Jan 4;142(1):37-46. doi: 10.7326/0003-4819-142-1-200501040-00110. Epub 2004 Nov 10. |
| 8417384 | Background | Parkinson Study Group. Effects of tocopherol and deprenyl on the progression of disability in early Parkinson's disease. N Engl J Med. 1993 Jan 21;328(3):176-83. doi: 10.1056/NEJM199301213280305. |
| 24664227 | Derived | Parkinson Study Group QE3 Investigators; Beal MF, Oakes D, Shoulson I, Henchcliffe C, Galpern WR, Haas R, Juncos JL, Nutt JG, Voss TS, Ravina B, Shults CM, Helles K, Snively V, Lew MF, Griebner B, Watts A, Gao S, Pourcher E, Bond L, Kompoliti K, Agarwal P, Sia C, Jog M, Cole L, Sultana M, Kurlan R, Richard I, Deeley C, Waters CH, Figueroa A, Arkun A, Brodsky M, Ondo WG, Hunter CB, Jimenez-Shahed J, Palao A, Miyasaki JM, So J, Tetrud J, Reys L, Smith K, Singer C, Blenke A, Russell DS, Cotto C, Friedman JH, Lannon M, Zhang L, Drasby E, Kumar R, Subramanian T, Ford DS, Grimes DA, Cote D, Conway J, Siderowf AD, Evatt ML, Sommerfeld B, Lieberman AN, Okun MS, Rodriguez RL, Merritt S, Swartz CL, Martin WR, King P, Stover N, Guthrie S, Watts RL, Ahmed A, Fernandez HH, Winters A, Mari Z, Dawson TM, Dunlop B, Feigin AS, Shannon B, Nirenberg MJ, Ogg M, Ellias SA, Thomas CA, Frei K, Bodis-Wollner I, Glazman S, Mayer T, Hauser RA, Pahwa R, Langhammer A, Ranawaya R, Derwent L, Sethi KD, Farrow B, Prakash R, Litvan I, Robinson A, Sahay A, Gartner M, Hinson VK, Markind S, Pelikan M, Perlmutter JS, Hartlein J, Molho E, Evans S, Adler CH, Duffy A, Lind M, Elmer L, Davis K, Spears J, Wilson S, Leehey MA, Hermanowicz N, Niswonger S, Shill HA, Obradov S, Rajput A, Cowper M, Lessig S, Song D, Fontaine D, Zadikoff C, Williams K, Blindauer KA, Bergholte J, Propsom CS, Stacy MA, Field J, Mihaila D, Chilton M, Uc EY, Sieren J, Simon DK, Kraics L, Silver A, Boyd JT, Hamill RW, Ingvoldstad C, Young J, Thomas K, Kostyk SK, Wojcieszek J, Pfeiffer RF, Panisset M, Beland M, Reich SG, Cines M, Zappala N, Rivest J, Zweig R, Lumina LP, Hilliard CL, Grill S, Kellermann M, Tuite P, Rolandelli S, Kang UJ, Young J, Rao J, Cook MM, Severt L, Boyar K. A randomized clinical trial of high-dosage coenzyme Q10 in early Parkinson disease: no evidence of benefit. JAMA Neurol. 2014 May;71(5):543-52. doi: 10.1001/jamaneurol.2014.131. |
Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
| FG002 | C. Placebo With Vitamin E 1200 IU/Day | Placebo (with vitamin E 1200 IU/day) |
| Reaching Endpoint Before May 6, 2011 |
|
| Active Patients at Study Termination |
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| COMPLETED |
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| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day | Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day) |
| BG001 | B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day | Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day) |
| BG002 | C. Placebo With Vitamin E 1200 IU/Day | Placebo (with vitamin E 1200 IU/day) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Total Score (Sum of Parts I, II and III Ranges From 0 to 176)) | Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline visit and month 16 or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first. The UPDRS score has three components, each consisting of questions answered on a 0-4 point scale. Part I assesses mentation, behavior and mood; Part II assesses activities of daily living in the week prior to the designated visit; and Part III assesses motor abilities at the time of the visit. A total of 31 items are included in Parts I, II and III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total score ranges from 0-176. | Eligible research participants were assigned by randomization to one of three treatment groups: CoQ10 2400 mg/day, CoQ10 1200 mg/day or matching placebo. All participants also received 1200 IU of vitamin E daily. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first |
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| Secondary | Change in Modified Schwab & England Independence Scale From Baseline to 16 Months | This scale measures activities of daily living. This is an investigator and subject assessment of the subject's level of independence at all scheduled visits. The subject is scored on a percentage scale reflective of his/her ability to perform acts of daily living in relation to pre-Parkinson disease ability. Scores range in increments of 10%: 100% for normal (subject is completely independent; essentially normal) to 0% (vegetative functions such as swallowing, bladder and bowel functions are not functioning; bedridden). | All participants were used in primary and secondary outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first |
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| Secondary | Change in Modified Rankin Scale From Baseline to 16 Months | The Modified Rankin Scale is a global functional health index with a strong accent on physical disability. Subjects are scored on a scale of 0 (no symptoms at all) to 5 (severe disability: bedridden incontinent, and requiring constant nursing care and attention. | All participants were used in primary and secondary outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first |
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| Secondary | Change in PD Quality of Life Scale From Baseline to 16 Months | The subject will complete a questionnaire that will evaluate how Parkinson disease has affected their health and overall quality of life at each visit. The total quality of life scale measures a total of 33 aspects of quality of life. Each aspect is rated on scale of 0 (best outcome) to 4 (worst outcome). Total score range is 0-132. A higher score or increased score compared to a previous visit indicates a lowered quality of life. | All participants were used in primary and secondary outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first |
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| Secondary | Change in Symbol Digit Modalities Test From Baseline to 16 Months | The Symbol Digit Modalities Test screens cognitive impairment by using a simple substitution tasks that individuals with normal functioning can easily perform. The test score range is from 0(worst outcome) to 110 (best outcome). | All participants were used in primary and secondary outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first |
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| Secondary | Change in Hoehn & Yahr Score From Baseline to 16 Months | The Modified Hoehn and Yahr Scale is an 8-level Parkinson disease staging instrument. The investigator will assess disease stage at each level. The disease stages range from the best outcome of 0 (no signs of disease) to the worst outcome of 5 (wheelchair bound or bedridden unless aided). | All participants were used in primary and secondary outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first |
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| Secondary | CoQ10 Levels in Plasma | Based on samples analyzed to date | All participants have been included and data is based on samples analyzed to date. | Posted | Mean | Standard Deviation | ug/ml | Baseline, 1, 8 and 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first |
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| Secondary | Adverse Experiences: Back Pain | Number of participants with back pain | All participants were used in primary and secondary outcome analysis. | Posted | Number | participants | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
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| Secondary | Adverse Experiences: Constipation | Number of participants with constipation | All participants were used in primary and secondary outcome analysis. | Posted | Number | participants | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
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| Secondary | Adverse Experiences: Insomnia | Number of participants with insomnia | All participants were used in primary and secondary outcome analysis. | Posted | Number | participants | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
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| Secondary | Adverse Experiences: Anxiety | Number of participants with anxiety | All participants were used in primary and secondary outcome analysis. | Posted | Number | participants | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
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| Secondary | Adverse Experiences: Tremor | Number of participants with tremor | All participants were used in primary and secondary outcome analysis. | Posted | Number | participants | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
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| Secondary | Adverse Experiences: Nasopharyngitis | Number of participants with nasopharyngitis | All participants were used in primary and secondary outcome analysis. | Posted | Number | participants | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
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| Secondary | Adverse Experiences: Diarrhoea | Number of participants with diarrhoea | All participants were used in primary and secondary outcome analysis. | Posted | Number | participants | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
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| Secondary | Adverse Experiences: Headache | Number of participants with headache | All participants were used in primary and secondary outcome analysis. | Posted | Number | participants | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
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| Secondary | Adverse Experiences: Urinary Tract Infection | Number of patients with urinary tract infections | All participants were used in primary and secondary outcome analysis. | Posted | Number | participants | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
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| Secondary | Adverse Experiences: Nausea | Number of participants with nausea | All participants were used in primary and secondary outcome analysis. | Posted | Number | participants | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
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| Secondary | Adverse Experiences: Hypertension | Number of participants with hypertension | All participants were used in primary and secondary outcome analysis. | Posted | Number | participants | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
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| Secondary | Adverse Experiences: Depression | Number of participants with depression | All participants were used in primary and secondary outcome analysis. | Posted | Number | participants | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
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| Secondary | Adverse Experiences: Constipation: Moderate/Severe | Number of participants with moderate/severe constipation | All participants were used in primary and secondary outcome analysis. | Posted | Number | participants | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
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| Secondary | Adverse Experiences: Anxiety: Moderate/Severe | Number of participants with moderate/severe anxiety | All participants were used in primary and secondary outcome analysis. | Posted | Number | participants | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
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| Secondary | Adverse Experiences: Back Pain: Moderate/Severe | Number of participants with moderate/severe back pain | All participants were used in primary and secondary outcome analysis. | Posted | Number | participants | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
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| Secondary | Adverse Experiences: Insomnia: Moderate/Severe | Number of participants with moderate/severe insomnia | All participants were used in primary and secondary outcome analysis. | Posted | Number | participants | Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) |
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Adverse events data were collected for a period of 2 years and 7 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day | Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day) | 7 | 196 | 106 | 196 | ||
| EG001 | B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day | Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day) | 13 | 201 | 113 | 201 | ||
| EG002 | C. Placebo With Vitamin E 1200 IU/Day | Placebo (with vitamin E 1200 IU/day) | 13 | 203 | 108 | 203 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac catheterization | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
| |
| Gastero-intestinal bleed | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Multiple myeloma | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Prostatitis | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pacemaker battery replacement | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cervical radiculopathy | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Back pain | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Bowel obstruction | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Vertigo | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Accident with fractures | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Total knee replacement | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
| |
| Gastric banding | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
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| Chest pain | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Pelvic floor dysfunction | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
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| Spinal stenosis | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Prostate cancer progression | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
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| Breast cancer | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pulmonary embolism | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Benign prostatic hypertrophy | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
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| Pneumonia | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Transurethral resection of the prostate | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
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| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Sudden death | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Dental infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Hypersensitivity pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Colon cancer | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Dehydration | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Subarachnoid hemorrhage | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Accident with fractures and head trauma | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Insomnia | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nasopharyngitis | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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The planned interim analysis for futility based on the first 300 subjects has reached the pre-specified termination criterion.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| M. Flint Beal, MD | Weill Medical College of Cornell University | 212-746-6575 | fbeal@med.cornell.edu |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C024989 | coenzyme Q10 |
| D014810 | Vitamin E |
| D014451 | Ubiquinone |
| ID | Term |
|---|---|
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D016227 | Benzoquinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Canada |
|
| ANCOVA is used with the change in total UPDRS of Coenzyme Q10 2400 mg/day arm compared to placebo group. | ANCOVA | >0.025 | The primary analysis compares each active treatment arm to the placebo arm. P-values for efficacy outcomes will be 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05. | Mean Difference (Net) | 1.09 | Standard Error of the Mean | 0.86 | 2-Sided | 95 | -0.85 | 3.03 | No | Superiority or Other |
Placebo (with vitamin E 1200 IU/day)
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