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| Name | Class |
|---|---|
| Instituto Mexicano del Seguro Social | OTHER_GOV |
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Introduction: Highly active antiretroviral therapy (HAART) has showed its effectiveness in the prevention of complications in seropositive for HIV patients. However, they develop some manifestations such as lipodystrophy, dyslipidemia, and glucose intolerance increasing cardiovascular risk.
Clinical trials in general population and in patients on hemodialysis have demonstrated a significant reduction in cardiovascular events using fish oil. Omega-3 fatty acids are believed to be beneficial in prevention of atherosclerosis reducing lipids levels specially triglycerides. Also in general populations it has been described a benefit effect of omega 3 acids on oxidative stress.
Objective: to know the effect of omega 3 acids on different markers of oxidative stress in seropositive HIV patients.
Methods: We will perform a randomized parallel controlled clinical trial in seropositive HIV patients from 20 to 55 years old on clinical score A1, A2, B1 or B2 who received HAART. They will be randomly assigned to receive omega 3 fatty acids 2.4 g (Zonelabs, Marblehead MA) or placebo for 6 months. At baseline anthropometric measurements, lipid profile, glucose and stress oxidative levels (nitric oxide, malondialdehyde, total glutathion, and lipid peroxidation products) will be evaluated.
Sample size was calculated according to different variables. We selected the biggest one calculated for a difference in nitric oxide of 25% after treatment between groups and a standard deviation (SD) value of 10µmol/L. Whit this information we obtained a sample size of 31 patients per group for an 80% statistical power with α= 0.05. Assuming a 15% patient lost, a sample size of 35 per group was considered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega 3 fatty acids | Experimental | omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months. |
|
| Placebo | Placebo Comparator | Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omega 3 fatty acids | Drug | omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change on Malondialdehyde After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients | The difference of this value at 6 months in relation to baseline value |
| Measure | Description | Time Frame |
|---|---|---|
| Change on Total Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients | The difference of this value at 6 months in relation to baseline value | |
| Change on Nitric Oxide After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norma Amador, PhD | Instituto Mexicano del Seguro Social | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Mexicano del Seguro Social | León | Guanajuato | 37320 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27015634 | Derived | Amador-Licona N, Diaz-Murillo TA, Gabriel-Ortiz G, Pacheco-Moises FP, Pereyra-Nobara TA, Guizar-Mendoza JM, Barbosa-Sabanero G, Orozco-Avina G, Moreno-Martinez SC, Luna-Montalban R, Vazquez-Valls E. Omega 3 Fatty Acids Supplementation and Oxidative Stress in HIV-Seropositive Patients. A Clinical Trial. PLoS One. 2016 Mar 25;11(3):e0151637. doi: 10.1371/journal.pone.0151637. eCollection 2016. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Omega 3 Fatty Acids | omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months. omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up. |
| FG001 | Placebo | Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1) omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omega 3 Fatty Acids | omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months. omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change on Malondialdehyde After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients | Posted | Mean | 95% Confidence Interval | nM/mg protein | The difference of this value at 6 months in relation to baseline value |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omega 3 Fatty Acids | omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months. omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Norma Amador | Instituto Mexicano del Seguro Social, UMAE HE No. 1 Bajio | +524777174800 | 31315 | norma.amador@imss.gob.mx |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D000069463 | Olive Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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|
| placebo | Other | olive oil in similar presentation of omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up. |
|
|
| The difference of this value at 6 months in relation to baseline value |
| Change on Viral Load After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients | The difference of this value at 6 months in relation to baseline value |
| Change on Oxidized- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients | The difference of this value at 6 months in relation to baseline value |
| Change on Reduced- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients | The difference of this value at 6 months in relation to baseline value |
| Change on Alanine Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients | The difference of this value at 6 months in relation to baseline value |
| Change on Aspartate Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients | The difference of this value at 6 months in relation to baseline value |
| Protocol Violation |
|
| Lost to Follow-up |
|
| Hypothiroidism identified during follow- |
|
| Placebo |
Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1) omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Systolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Glucose | Mean | Standard Deviation | mg/dL |
|
| Total cholesterol | Median | Inter-Quartile Range | mg/dL |
|
| Triglycerides | Median | Inter-Quartile Range | mg/dL |
|
| HDL cholesterol | Median | Inter-Quartile Range | mg/dL |
|
| LDL cholesterol | Median | Inter-Quartile Range | mg/dL |
|
| VLDL cholesterol | Median | Inter-Quartile Range | mg/dL |
|
| Time in HAART | Median | Inter-Quartile Range | months |
|
| Alanine aminotransferase | Median | Inter-Quartile Range | UI/L |
|
| Aspartate aminotransferase | Median | Inter-Quartile Range | UI/L |
|
| Lipoperoxides | Median | Inter-Quartile Range | nM/mg protein |
|
| Total-glutathione | Median | Inter-Quartile Range | μM |
|
| Oxidized-glutathione | Median | Inter-Quartile Range | μM |
|
| Reduced-glutathione | Median | Inter-Quartile Range | μM |
|
| Nitric oxide catabolites | Mean | Standard Deviation | μM/ml |
|
| CD4 | Median | Inter-Quartile Range | cel/µL |
|
| CD8 | Median | Inter-Quartile Range | cel/µL |
|
|
|
| Secondary | Change on Total Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients | Posted | Mean | 95% Confidence Interval | µM | The difference of this value at 6 months in relation to baseline value |
|
|
|
| Secondary | Change on Nitric Oxide After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients | Posted | Mean | Standard Deviation | µM/ml | The difference of this value at 6 months in relation to baseline value |
|
|
|
| Secondary | Change on Viral Load After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients | Posted | Mean | 95% Confidence Interval | copies/ml | The difference of this value at 6 months in relation to baseline value |
|
|
|
| Secondary | Change on Oxidized- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients | Posted | Mean | 95% Confidence Interval | µM | The difference of this value at 6 months in relation to baseline value |
|
|
|
| Secondary | Change on Reduced- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients | Posted | Mean | 95% Confidence Interval | µM | The difference of this value at 6 months in relation to baseline value |
|
|
|
| Secondary | Change on Alanine Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients | Posted | Mean | 95% Confidence Interval | UI/L | The difference of this value at 6 months in relation to baseline value |
|
|
|
| Secondary | Change on Aspartate Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients | Posted | Mean | 95% Confidence Interval | UI/L | The difference of this value at 6 months in relation to baseline value |
|
|
|
| 0 |
| 35 |
| 2 |
| 35 |
| EG001 | Placebo | Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1) omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up. | 0 | 35 | 1 | 35 |
| dizzines | Nervous system disorders |
|
| biliar colic in patiet with cholelithiasis | Gastrointestinal disorders |
|
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |