Cancer Clinical Trial - Clinical Trial of Vitamin D3 to Reduce Cancer Risk

Status Completed

Clinical Trial Summary

To determine the effect of increasing serum 25(OH)D from prevailing levels with vitamin D3 supplementation, while maintaining adequate calcium intake, on incidence of all-type cancer in a population sample of healthy postmenopausal women.

Clinical Trial Description

Hypotheses:

Primary: Increasing serum 25(OH)D from prevailing levels with vitamin D3 supplementation, while maintaining adequate calcium intake, will significantly decrease incidence of all-type cancer in a population sample of healthy postmenopausal women.

Secondary:

1. Increasing serum 25(OH)D from prevailing levels will significantly decrease incidence of specific cancers: breast, lung, colon, myeloma, leukemia, lymphoma.

2. Increasing serum 25OHD from prevailing levels will significantly decrease incidence of other disorders, specifically hypertension, cardiovascular disease, osteoarthritis, colonic adenomas, diabetes, upper respiratory infections and falls.

Specific Aims:

1. Determine the effect of supplementation with vitamin D3 on incidence of all types of cancer combined.

2. Determine in a nested-case control study the association of serum 25OHD collected at randomization and at the end of year one of study with risk of cancer over four years.

3. Sample randomly the population of healthy independently-living postmenopausal women 55 years and older from twelve adjacent rural counties in Nebraska.

4. Enroll a random sample of 2300 women into an intervention study, assign them randomly to one of two treatment groups: 1) vitamin D3 (2000 IU/d) and calcium (1500 mg/d), or 2) vitamin D3 placebo and calcium placebo, and to follow each study participant for four years.

5. Collect and store blood serum and white blood cells from every participant to test for genetic markers should the intervention be found effective in decreasing the incidence of cancer. Markers selected will be determined by the state of the science at the time of analysis.

6. Determine the effect of supplementation with calcium and vitamin D3 on incidence of specific cancers: breast, lung, colon, myeloma, leukemia, and lymphoma.

7. Determine the effect of supplementation on incidence of other disorders, specifically hypertension, cardiovascular disease, osteoarthritis, colonic adenomas, diabetes, upper respiratory infections, fractures, and falls. ;

Study Design

Related Conditions & MeSH terms

Cancer

Clinical Trial Details

NCT number	NCT01052051
Study type	Interventional
Source	Creighton University
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	June 2009
Completion date	August 2015

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial of Vitamin D3 to Reduce Cancer Risk in Postmenopausal Women — CAPS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms