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Vitamin D for Chemoprevention
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Phase
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Type
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Status
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Age
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Protocol IDs
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Phase I
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Biomarker/Laboratory analysis, Prevention
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Active
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30 to 80
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Other
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07-342
NCT00585637
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Trial Description
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. Further Study Information - 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 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
- Active thyroid disease (e.g. Graves, Hashimoto's or thyroiditis)
- History of nephrolithiasis, chronic liver disease, chronic renal disease, or renal dialysis
Trial Contact Information
Trial Lead Organizations/Sponsors Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Harvard School of Public Health
| Edward Giovannucci, MD, ScD | | Principal Investigator |
| Gary G Bennett, PhD | | Study Director |
Trial Sites
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| U.S.A. |
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| Massachusetts |
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Boston |
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| | | | | | | | | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00585637
Information obtained from ClinicalTrials.gov on August 15, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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