Vitamin D for Chemoprevention

Phase 1

Completed

• Conditions: Hypertension; Prostate Cancer; Gastrointestinal Cancers
• Interventions: Drug: Vitamin D; Dietary Supplement: Placebo

• Registration Number: NCT00585637
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-24
• Study First Submitted QC: 2008-01-02
• Study First Posted: 2008-01-03
• Primary Completion: 2010-10
• Study Completion: 2013-12
• Status Verified: 2015-03
• Results First Submitted: 2015-03-03
• Results First Submitted QC: 2015-03-18
• Last Update Submitted: 2015-03-18
• Results First Posted: 2015-04-01
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 328

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
4	Vitamin D	4000 IU of Vitamin D
1	Placebo	No Vitamin D
2	Vitamin D	1000 IU of Vitamin D
3	Vitamin D	2000 IU of Vitamin D

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States