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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
Sponsor:
Collaborator:
Harvard School of Public Health
Information provided by (Responsible Party):
Kimmie Ng, MD, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE December 24, 2007
First Posted Date  ICMJE January 3, 2008
Results First Submitted Date  ICMJE March 3, 2015
Results First Posted Date  ICMJE April 1, 2015
Last Update Posted Date April 1, 2015
Study Start Date  ICMJE October 2007
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 2, 2008)
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 ]
Change History Complete list of historical versions of study NCT00585637 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D for Chemoprevention
Official Title  ICMJE Defining Optimal Doses of Vitamin D for Chemoprevention in Blacks.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Gastrointestinal Cancers
  • Prostate Cancer
  • Hypertension
Intervention  ICMJE
  • Drug: Vitamin D
    Taken orally every day for three months
  • Dietary Supplement: Placebo
    Placebo pill taken once daily for 3 month
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2011)
328
Original Estimated Enrollment  ICMJE
 (submitted: January 2, 2008)
320
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00585637
Other Study ID Numbers  ICMJE 07-342
P15192 ( Other Identifier: Harvard School of Public Health )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kimmie Ng, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE Harvard School of Public Health
Investigators  ICMJE
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
PRS Account Dana-Farber Cancer Institute
Verification Date March 2015

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