Vitamin D for Chemoprevention - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Harvard School of Public Health
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00585637

Purpose

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	Intervention	Phase
Gastrointestinal Cancers Prostate Cancer Hypertension	Dietary Supplement: Vitamin D Dietary Supplement: Placebo	Phase I

MedlinePlus related topics: Cancer Dietary Supplements High Blood Pressure Prostate Cancer

Drug Information available for: Vitamin D Ergocalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study
Official Title:	Defining Optimal Doses of Vitamin D for Chemoprevention in Blacks.

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	320
Study Start Date:	October 2007
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator No Vitamin D	Dietary Supplement: Placebo Placebo pill taken once daily for 3 month
2: Active Comparator 1000 IU of Vitamin D	Dietary Supplement: Vitamin D Taken orally every day for three months
3: Active Comparator 2000 IU of Vitamin D	Dietary Supplement: Vitamin D Taken orally every day for three months
4: Active Comparator 4000 IU of Vitamin D	Dietary Supplement: Vitamin D Taken orally every day for three months

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.

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585637

Contacts

Contact: Karen Emmons, PhD		kemmons@partners.org
Contact: Charles Fuchs, MD	(617) 632-5840	Charles_Fuchs@dfci.harvard.edu

Locations

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

Sponsors and Collaborators

Dana-Farber Cancer Institute

Harvard School of Public Health

Investigators

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

Responsible Party:	Dana-Farber Cancer Institute ( Karen Emmons )
Study ID Numbers:	07-342
Study First Received:	December 24, 2007
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00585637
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

Vitamin D
Blacks
cancer
hypertension

Study placed in the following topic categories:

Digestive System Neoplasms
Genital Neoplasms, Male
Prostatic Diseases
Gastrointestinal Diseases
Vascular Diseases
Ergocalciferols
Urogenital Neoplasms

Genital Diseases, Male
Digestive System Diseases
Vitamin D
Gastrointestinal Neoplasms
Prostatic Neoplasms
Hypertension

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Growth Substances
Vitamins
Physiological Effects of Drugs

Bone Density Conservation Agents
Cardiovascular Diseases
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009