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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
History of Changes
  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
 Drug: Vitamin D
Dietary Supplement: Placebo
 Phase 1

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

Resource links provided by NLM:

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

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 ]

Enrollment: 328
Study Start Date: October 2007
Estimated Study Completion Date: December 2013
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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
  More Information

No publications provided by Dana-Farber Cancer Institute

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

Responsible Party: Karen Emmons, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00585637     History of Changes
Other Study ID Numbers: 07-342, P15192
Study First Received: December 24, 2007
Last Updated: January 23, 2013
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

Additional relevant MeSH terms:
Hypertension
Prostatic Neoplasms
Gastrointestinal Neoplasms
Vascular Diseases
Cardiovascular Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
 Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on June 18, 2013