Gastrointestinal Cancers, Hypertension, Prostate Cancer
Conditions
Keywords
Vitamin D, Blacks, cancer, hypertension
Brief summary
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.
Detailed description
* Participants will be asked to answer some questions about their diet, exercise and health. In addition, participants blood pressure will be taken. These assessments will occur at baseline, 3- and 6-month appointments. At baseline only, we will measure skin tone with a tool called the Photovolt 577. * A small blood sample will be taken to see how much Vitamin D is the body and will also look at levels of other markers of disease such as proteins, hormones, and genes. * Participants will take a vitamin pill every day for three months and be randomly assigned to one of four different types of pills. * Participants will be called or visited at least every two weeks. They will be asked questions to determine if they have any side effects associated with high levels of Vitamin D. * At the beginning of the second and third months, participants will be provided with more pills. At the end of the third month, another blood sample will be taken. Three months after that, the final blood sample will be taken.
Interventions
DRUGVitamin D
Taken orally every day for three months
DIETARY_SUPPLEMENTPlacebo
Placebo pill taken once daily for 3 month
Sponsors
Harvard School of Public Health (HSPH)
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Between the ages of 30 and 80 years * Comfortable communicating in English * Currently has a primary care physician * Willing to discontinue vitamin D or calcium supplements * Willing to have all protocol specific tests run
Exclusion criteria
* Plans on taking a vacation or travel to a sunny region within 3 months of vitamin supplementation period except for a short period (i.e. 1 weekend) * Pregnant or breast feeding or planning on becoming pregnant in the following year * Pre-existing calcium (including hypercalcemia), parathyroid conditions (including hyperparathyroidism), sarcoidosis * No concurrent active malignancies (other than non-melanoma skin cancer) or previous diagnosis of prostate cancer * Cognitively impaired * Active thyroid disease (e.g. Graves, Hashimoto's or thyroiditis) * History of nephrolithiasis, chronic liver disease, chronic renal disease, or renal dialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months. | Baseline, 3months, 6months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in IL-6 From 0 to 3 Months. | From baseline to 3 months | Examine the influence of oral vitamin D supplementation on inflammatory marker IL-6 from baseline to the 3 month follow-up. |
| Change in IL-10 From 0 to 3 Months. | From baseline to 3 months | Examine the influence of oral vitamin D supplementation on inflammatory marker IL-10 from baseline to the 3 month follow-up. |
| Change in sTNF-R2 From 0 to 3 Months. | From baseline to 3 months | Examine the influence of oral vitamin D supplementation on inflammatory marker sTNF-R2 from baseline to the 3 month follow-up. |
| Change in CRP From 0 to 3 Months. | From baseline to 3 months | Examine the influence of oral vitamin D supplementation on inflammatory marker CRP from baseline to the 3 month follow-up. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| No Vitamin D No Vitamin D
Placebo: Placebo pill taken once daily for 3 month | 81 |
| 1000 IU of Vitamin D 1000 IU of Vitamin D
Vitamin D: Taken orally every day for three months | 81 |
| 2000 IU of Vitamin D 2000 IU of Vitamin D
Vitamin D: Taken orally every day for three months | 83 |
| 4000 IU of Vitamin D 4000 IU of Vitamin D
Vitamin D: Taken orally every day for three months | 83 |
| Total | 328 |
Baseline characteristics
| Characteristic | No Vitamin D | Total | 4000 IU of Vitamin D | 2000 IU of Vitamin D | 1000 IU of Vitamin D |
|---|---|---|---|---|---|
| Age, Continuous | 50.7 years | 51.0 years | 51.3 years | 50.3 years | 51.1 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 81 Participants | 328 Participants | 83 Participants | 83 Participants | 81 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 81 participants | 328 participants | 83 participants | 83 participants | 81 participants |
| Sex: Female, Male Female | 54 Participants | 222 Participants | 54 Participants | 55 Participants | 59 Participants |
| Sex: Female, Male Male | 27 Participants | 106 Participants | 29 Participants | 28 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 3 / 28 | 1 / 31 | 1 / 31 |
| serious Total, serious adverse events | 0 / 81 | 0 / 81 | 0 / 83 | 0 / 83 |
Outcome results
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.
Time frame: Baseline, 3months, 6months
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| No Vitamin D | Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months. | Baseline 25(OH)D | 15.1 ng/mL |
| No Vitamin D | Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months. | 25(OH)D at 6 months | 18.1 ng/mL |
| No Vitamin D | Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months. | 25(OH)D at 3 months | 13.7 ng/mL |
| 1000 IU of Vitamin D | Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months. | Baseline 25(OH)D | 16.2 ng/mL |
| 1000 IU of Vitamin D | Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months. | 25(OH)D at 6 months | 21.2 ng/mL |
| 1000 IU of Vitamin D | Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months. | 25(OH)D at 3 months | 29.7 ng/mL |
| 2000 IU of Vitamin D | Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months. | 25(OH)D at 3 months | 34.8 ng/mL |
| 2000 IU of Vitamin D | Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months. | Baseline 25(OH)D | 13.9 ng/mL |
| 2000 IU of Vitamin D | Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months. | 25(OH)D at 6 months | 27.0 ng/mL |
| 4000 IU of Vitamin D | Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months. | Baseline 25(OH)D | 15.7 ng/mL |
| 4000 IU of Vitamin D | Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months. | 25(OH)D at 6 months | 31.2 ng/mL |
| 4000 IU of Vitamin D | Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months. | 25(OH)D at 3 months | 45.9 ng/mL |
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.
Time frame: From baseline to 3 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| No Vitamin D | Change in CRP From 0 to 3 Months. | -0.05 mg/L |
| 1000 IU of Vitamin D | Change in CRP From 0 to 3 Months. | 0.07 mg/L |
| 2000 IU of Vitamin D | Change in CRP From 0 to 3 Months. | 0.02 mg/L |
| 4000 IU of Vitamin D | Change in CRP From 0 to 3 Months. | 0.03 mg/L |
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.
Time frame: From baseline to 3 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| No Vitamin D | Change in IL-10 From 0 to 3 Months. | 0 pg/mL |
| 1000 IU of Vitamin D | Change in IL-10 From 0 to 3 Months. | -0.01 pg/mL |
| 2000 IU of Vitamin D | Change in IL-10 From 0 to 3 Months. | -0.02 pg/mL |
| 4000 IU of Vitamin D | Change in IL-10 From 0 to 3 Months. | 0.00 pg/mL |
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.
Time frame: From baseline to 3 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| No Vitamin D | Change in IL-6 From 0 to 3 Months. | -0.03 pg/mL |
| 1000 IU of Vitamin D | Change in IL-6 From 0 to 3 Months. | -0.07 pg/mL |
| 2000 IU of Vitamin D | Change in IL-6 From 0 to 3 Months. | 0.01 pg/mL |
| 4000 IU of Vitamin D | Change in IL-6 From 0 to 3 Months. | 0.08 pg/mL |
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.
Time frame: From baseline to 3 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| No Vitamin D | Change in sTNF-R2 From 0 to 3 Months. | -0.89 pg/mL |
| 1000 IU of Vitamin D | Change in sTNF-R2 From 0 to 3 Months. | -9.88 pg/mL |
| 2000 IU of Vitamin D | Change in sTNF-R2 From 0 to 3 Months. | 59.16 pg/mL |
| 4000 IU of Vitamin D | Change in sTNF-R2 From 0 to 3 Months. | 13.29 pg/mL |