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| ID | Type | Description | Link |
|---|---|---|---|
| P15192 | Other Identifier | Harvard School of Public Health |
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| Name | Class |
|---|---|
| Harvard School of Public Health (HSPH) | OTHER |
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This study will help us know the effects of Vitamin D pills in Blacks. The results of this study may be the first step in creating ways to prevent the risks of colon and prostate cancer. It will also help us develop ways to reduce colon cancer and prostate cancer among Blacks. This study will find out if Vitamin D pills can increase Vitamin D to healthy levels in our bodies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | No Vitamin D |
|
| 2 | Active Comparator | 1000 IU of Vitamin D |
|
| 3 | Active Comparator | 2000 IU of Vitamin D |
|
| 4 | Active Comparator | 4000 IU of Vitamin D |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | Taken orally every day for three months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months. | Among Blacks, identify a dose of oral vitamin D supplementation that will result in levels of plasma 25(OH)D that would be predicted to reduce colorectal cancer incidence. Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston. | Baseline, 3months, 6months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in IL-6 From 0 to 3 Months. | Examine the influence of oral vitamin D supplementation on inflammatory marker IL-6 from baseline to the 3 month follow-up. | From baseline to 3 months |
| Change in IL-10 From 0 to 3 Months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Giovannucci, MD, ScD | Harvard School of Public Health/Brigham and Women's Hospital | Principal Investigator |
| Gary G Bennett, PhD | Dana-Farber Cancer Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24657333 | Result | Chandler PD, Scott JB, Drake BF, Ng K, Forman JP, Chan AT, Bennett GG, Hollis BW, Giovannucci EL, Emmons KM, Fuchs CS. Risk of hypercalcemia in blacks taking hydrochlorothiazide and vitamin D. Am J Med. 2014 Aug;127(8):772-8. doi: 10.1016/j.amjmed.2014.02.044. Epub 2014 Mar 20. | |
| 24368437 | Result | Ng K, Scott JB, Drake BF, Chan AT, Hollis BW, Chandler PD, Bennett GG, Giovannucci EL, Gonzalez-Suarez E, Meyerhardt JA, Emmons KM, Fuchs CS. Dose response to vitamin D supplementation in African Americans: results of a 4-arm, randomized, placebo-controlled trial. Am J Clin Nutr. 2014 Mar;99(3):587-98. doi: 10.3945/ajcn.113.067777. Epub 2013 Dec 24. |
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This study recruited community-based African American (www.clinicaltrials.gov; NCT00585637). Participants were drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.
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| ID | Title | Description |
|---|---|---|
| FG000 | No Vitamin D | No Vitamin D Placebo: Placebo pill taken once daily for 3 month |
| FG001 | 1000 IU of Vitamin D | 1000 IU of Vitamin D Vitamin D: Taken orally every day for three months |
| FG002 | 2000 IU of Vitamin D | 2000 IU of Vitamin D Vitamin D: Taken orally every day for three months |
| FG003 | 4000 IU of Vitamin D | 4000 IU of Vitamin D Vitamin D: Taken orally every day for three months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| 3-month Time Point |
| |||||||||||||
| 6-month Time Point |
|
Participants were drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.
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| ID | Title | Description |
|---|---|---|
| BG000 | No Vitamin D | No Vitamin D Placebo: Placebo pill taken once daily for 3 month |
| BG001 | 1000 IU of Vitamin D | 1000 IU of Vitamin D Vitamin D: Taken orally every day for three months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months. | Among Blacks, identify a dose of oral vitamin D supplementation that will result in levels of plasma 25(OH)D that would be predicted to reduce colorectal cancer incidence. Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston. | Number of participants analyzed above is for baseline. At 3 months, number of participants analyzed was: 71 (no vitamin D), 67 (1000 IU Vitamin D), 76 (2000 IU Vitamin D) and 78 (4000 IU Vitamin D). At 6 months, number of participants analyzed was: 75 (no vitamin D), 68 (1000 IU Vitamin D), 72 (2000 IU Vitamin D) and 77 (4000 IU Vitamin D). | Posted | Median | Inter-Quartile Range | ng/mL | Baseline, 3months, 6months |
|
Every 2 weeks, up to 6 months.
Participants were assessed every 2 weeks. The table for 'Other (Non-Serious) Adverse Events' only reports on a subset of patients as calcium levels were only checked in a subset of patients. Although all patients were evaluated for adverse events, the only reported adverse event was hypercalcemia.
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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 | No Vitamin D | No Vitamin D Placebo: Placebo pill taken once daily for 3 month |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypercalcemia at 1 month | Metabolism and nutrition disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimmie Ng, MD, MPH | Dana-Farber Cancer Institute | 617-632-4150 | Kimmie_Ng@dfci.harvard.edu |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D011471 | Prostatic Neoplasms |
| D006973 | Hypertension |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Placebo |
| Dietary Supplement |
Placebo pill taken once daily for 3 month |
|
Examine the influence of oral vitamin D supplementation on inflammatory marker IL-10 from baseline to the 3 month follow-up.
| From baseline to 3 months |
| Change in sTNF-R2 From 0 to 3 Months. | Examine the influence of oral vitamin D supplementation on inflammatory marker sTNF-R2 from baseline to the 3 month follow-up. | From baseline to 3 months |
| Change in CRP From 0 to 3 Months. | Examine the influence of oral vitamin D supplementation on inflammatory marker CRP from baseline to the 3 month follow-up. | From baseline to 3 months |
| 24327720 | Result | Chandler PD, Scott JB, Drake BF, Ng K, Manson JE, Rifai N, Chan AT, Bennett GG, Hollis BW, Giovannucci EL, Emmons KM, Fuchs CS. Impact of vitamin D supplementation on inflammatory markers in African Americans: results of a four-arm, randomized, placebo-controlled trial. Cancer Prev Res (Phila). 2014 Feb;7(2):218-25. doi: 10.1158/1940-6207.CAPR-13-0338-T. Epub 2013 Dec 10. |
| 26858840 | Derived | Chandler PD, Agboola F, Ng K, Scott JB, Drake BF, Bennett GG, Chan AT, Hollis BW, Emmons KM, Fuchs CS, Giovannucci EL. Reduction of Parathyroid Hormone with Vitamin D Supplementation in Blacks: A Randomized Controlled Trial. BMC Nutr. 2015;1:26. doi: 10.1186/s40795-015-0024-8. Epub 2015 Dec 17. |
| 24974387 | Derived | Chandler PD, Giovannucci EL, Scott JB, Bennett GG, Ng K, Chan AT, Hollis BW, Emmons KM, Fuchs CS, Drake BF. Null association between vitamin D and PSA levels among black men in a vitamin D supplementation trial. Cancer Epidemiol Biomarkers Prev. 2014 Sep;23(9):1944-7. doi: 10.1158/1055-9965.EPI-14-0522. Epub 2014 Jun 28. |
| 23487599 | Derived | Forman JP, Scott JB, Ng K, Drake BF, Suarez EG, Hayden DL, Bennett GG, Chandler PD, Hollis BW, Emmons KM, Giovannucci EL, Fuchs CS, Chan AT. Effect of vitamin D supplementation on blood pressure in blacks. Hypertension. 2013 Apr;61(4):779-85. doi: 10.1161/HYPERTENSIONAHA.111.00659. |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | 2000 IU of Vitamin D | 2000 IU of Vitamin D Vitamin D: Taken orally every day for three months |
| BG003 | 4000 IU of Vitamin D | 4000 IU of Vitamin D Vitamin D: Taken orally every day for three months |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
No Vitamin D
Placebo: Placebo pill taken once daily for 3 month
| OG001 | 1000 IU of Vitamin D | 1000 IU of Vitamin D Vitamin D: Taken orally every day for three months |
| OG002 | 2000 IU of Vitamin D | 2000 IU of Vitamin D Vitamin D: Taken orally every day for three months |
| OG003 | 4000 IU of Vitamin D | 4000 IU of Vitamin D Vitamin D: Taken orally every day for three months |
|
|
| Secondary | Change in IL-6 From 0 to 3 Months. | Examine the influence of oral vitamin D supplementation on inflammatory marker IL-6 from baseline to the 3 month follow-up. | Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston. | Posted | Median | Inter-Quartile Range | pg/mL | From baseline to 3 months |
|
|
|
| Secondary | Change in IL-10 From 0 to 3 Months. | Examine the influence of oral vitamin D supplementation on inflammatory marker IL-10 from baseline to the 3 month follow-up. | Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston. | Posted | Median | Inter-Quartile Range | pg/mL | From baseline to 3 months |
|
|
|
| Secondary | Change in sTNF-R2 From 0 to 3 Months. | Examine the influence of oral vitamin D supplementation on inflammatory marker sTNF-R2 from baseline to the 3 month follow-up. | Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston. | Posted | Median | Inter-Quartile Range | pg/mL | From baseline to 3 months |
|
|
|
| Secondary | Change in CRP From 0 to 3 Months. | Examine the influence of oral vitamin D supplementation on inflammatory marker CRP from baseline to the 3 month follow-up. | Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston. | Posted | Median | Inter-Quartile Range | mg/L | From baseline to 3 months |
|
|
|
| 0 |
| 81 |
| 0 |
| 29 |
| EG001 | 1000 IU of Vitamin D | 1000 IU of Vitamin D Vitamin D: Taken orally every day for three months | 0 | 81 | 3 | 28 |
| EG002 | 2000 IU of Vitamin D | 2000 IU of Vitamin D Vitamin D: Taken orally every day for three months | 0 | 83 | 1 | 31 |
| EG003 | 4000 IU of Vitamin D | 4000 IU of Vitamin D Vitamin D: Taken orally every day for three months | 0 | 83 | 1 | 31 |
| hypercalcemia at 3 months | Metabolism and nutrition disorders |
|
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| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |