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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

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 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

Drug Information available for: Vitamin D
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
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

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
United States, Massachusetts
Dana-Farber Cancer Institute
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

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kimmie Ng, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00585637     History of Changes
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:
Hypertension
Gastrointestinal Neoplasms
Vascular Diseases
Cardiovascular Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents