Overview

This trial is active, not recruiting.

Conditions gastrointestinal cancers, prostate cancer, hypertension
Treatments vitamin d, placebo
Phase phase 1
Sponsor Dana-Farber Cancer Institute
Collaborator Harvard School of Public Health
Start date October 2007
End date October 2010
Trial size 328 participants
Trial identifier NCT00585637, 07-342, P15192

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
No Vitamin D
placebo
Placebo pill taken once daily for 3 month
(Active Comparator)
1000 IU of Vitamin D
vitamin d
Taken orally every day for three months
(Active Comparator)
2000 IU of Vitamin D
vitamin d
Taken orally every day for three months
(Active Comparator)
4000 IU of Vitamin D
vitamin d
Taken orally every day for three months

Primary Outcomes

Measure
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.
time frame: Baseline, 3months, 6months

Secondary Outcomes

Measure
Examine the influence of oral vitamin D supplementation on inflammatory markers and compare germline polymorphic variation in Vitamin D pathway genes between Blacks and a cohort of Whites.
time frame: Baseline, 3months, 6months

Eligibility Criteria

Male or female participants from 30 years up to 80 years old.

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

Additional Information

Official title Defining Optimal Doses of Vitamin D for Chemoprevention in Blacks.
Principal investigator Edward Giovannucci, MD, ScD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.