Vitamin D for Chemoprevention

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ClinicalTrials.gov Identifier: NCT00585637

Recruitment Status : Completed

First Posted : January 3, 2008

Results First Posted : April 1, 2015

Last Update Posted : April 1, 2015

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Harvard School of Public Health (HSPH)

Information provided by (Responsible Party):

Kimmie Ng, MD, Dana-Farber Cancer Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gastrointestinal Cancers Prostate Cancer Hypertension	Drug: Vitamin D Dietary Supplement: Placebo	Phase 1

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	328 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Defining Optimal Doses of Vitamin D for Chemoprevention in Blacks.
Study Start Date :	October 2007
Actual Primary Completion Date :	October 2010
Actual Study Completion Date :	December 2013

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Hypertension Prostate cancer

MedlinePlus related topics: Vitamin D

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1 No Vitamin D	Dietary Supplement: Placebo Placebo pill taken once daily for 3 month
Active Comparator: 2 1000 IU of Vitamin D	Drug: Vitamin D Taken orally every day for three months
Active Comparator: 3 2000 IU of Vitamin D	Drug: Vitamin D Taken orally every day for three months
Active Comparator: 4 4000 IU of Vitamin D	Drug: Vitamin D Taken orally every day for three months

Outcome Measures

Primary Outcome Measures :

Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months. [ Time Frame: 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 :

Change in IL-6 From 0 to 3 Months. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	30 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585637

Locations

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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Harvard School of Public Health (HSPH)

Investigators

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Principal Investigator:	Edward Giovannucci, MD, ScD	Harvard School of Public Health/Brigham and Women's Hospital
Study Director:	Gary G Bennett, PhD	Dana-Farber Cancer Institute

More Information

Publications of Results:

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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Responsible Party:	Kimmie Ng, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00585637
Other Study ID Numbers:	07-342 P15192 ( Other Identifier: Harvard School of Public Health )
First Posted:	January 3, 2008 Key Record Dates
Results First Posted:	April 1, 2015
Last Update Posted:	April 1, 2015
Last Verified:	March 2015

Keywords provided by Kimmie Ng, MD, Dana-Farber Cancer Institute:


Vitamin D Blacks cancer hypertension

Additional relevant MeSH terms:

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Gastrointestinal Neoplasms Hypertension Vascular Diseases Cardiovascular Diseases Neoplasms by Site Neoplasms Digestive System Neoplasms	Digestive System Diseases Gastrointestinal Diseases Vitamin D Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents

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