Vitamin D for Chemoprevention

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Harvard School of Public Health
Information provided by (Responsible Party):
Karen Emmons, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00585637
First received: December 24, 2007
Last updated: January 23, 2013
Last verified: January 2013

December 24, 2007
January 23, 2013
October 2007
October 2010   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00585637 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Vitamin D for Chemoprevention
Defining Optimal Doses of Vitamin D for Chemoprevention in Blacks.

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.

  • 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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Gastrointestinal Cancers
  • Prostate Cancer
  • Hypertension
  • Drug: Vitamin D
    Taken orally every day for three months
  • Dietary Supplement: Placebo
    Placebo pill taken once daily for 3 month
  • Active Comparator: 1
    No Vitamin D
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: 2
    1000 IU of Vitamin D
    Intervention: Drug: Vitamin D
  • Active Comparator: 3
    2000 IU of Vitamin D
    Intervention: Drug: Vitamin D
  • Active Comparator: 4
    4000 IU of Vitamin D
    Intervention: Drug: Vitamin D

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
328
December 2013
October 2010   (final data collection date for primary outcome measure)

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
Both
30 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00585637
07-342, P15192
Yes
Karen Emmons, PhD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Harvard School of Public Health
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
Dana-Farber Cancer Institute
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP