Vitamin D for Chemoprevention

Hypertension Clinical Trial

Official title:

Defining Optimal Doses of Vitamin D for Chemoprevention in Blacks.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00585637
• Other study ID #: 07-342
• Secondary ID: P15192
• Status: Completed
• Phase: Phase 1
• First received: December 24, 2007
• Last updated: March 18, 2015
• Start date: October 2007
• Est. completion date: December 2013

Study information

• Verified date: March 2015
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: December 2013
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Gastrointestinal Cancers
• Gastrointestinal Neoplasms
• Hypertension
• Prostate Cancer

Intervention

Drug:
• Vitamin D
Taken orally every day for three months

Dietary Supplement:
• Placebo
Placebo pill taken once daily for 3 month

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Harvard School of Public Health

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 — View Citation

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-co — View Citation

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-controll — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline, 3months, 6months	No
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.	From baseline to 3 months	No
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.	From baseline to 3 months	No
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.	From baseline to 3 months	No
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.	From baseline to 3 months	No