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NCT Number: NCT00585637

Vitamin D for Chemoprevention

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.

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Key information

Conditions

Gastrointestinal Cancers Cardiovascular Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hypertension Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Drug

Taken orally every day for three months

Placebo

Dietary Supplement

Placebo pill taken once daily for 3 month

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Harvard School of Public Health (HSPH)

Registry information

Official study title

Defining Optimal Doses of Vitamin D for Chemoprevention in Blacks.

Important dates

Study start
2007
Primary completion
2010
Study completion
2013
First posted
Jan 3, 2008
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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