Clinical Trial of Vitamin D3 to Reduce Cancer Risk in Postmenopausal Women (CAPS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01052051|
Recruitment Status : Completed
First Posted : January 20, 2010
Last Update Posted : September 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Dietary Supplement: Vitamin D Dietary Supplement: Calcium||Phase 3|
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.
- Increasing serum 25(OH)D from prevailing levels will significantly decrease incidence of specific cancers: breast, lung, colon, myeloma, leukemia, lymphoma.
- 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.
- Determine the effect of supplementation with vitamin D3 on incidence of all types of cancer combined.
- 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.
- Sample randomly the population of healthy independently-living postmenopausal women 55 years and older from twelve adjacent rural counties in Nebraska.
- 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.
- 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.
- Determine the effect of supplementation with calcium and vitamin D3 on incidence of specific cancers: breast, lung, colon, myeloma, leukemia, and lymphoma.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2303 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Clinical Trial of Vitamin D3 to Reduce Cancer Risk in Postmenopausal Women|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Active Comparator: calcium
Daily calcium supplementation
Dietary Supplement: Calcium
Calcium 1200mg / daily
Experimental: Vitamin D
Daily Calcium and Vitamin D supplementation
Dietary Supplement: Vitamin D
Vitamin D 2000 IU/daily
- The primary outcome measure will be a cancer diagnosis. [ Time Frame: 5 years ]
- Determine whether the achieved level of serum 25OHD at the end of year one of study predicts risk of cancer over four years [ Time Frame: 5 years ]The secondary outcome will be cancer diagnosis.
- The secondary outcomes will be: 1. cancers: breast, lung, colon, myeloma, leukemia, lymphoma and 2. hypertension, cardiovascular disease, osteoarthritis, colonic adenomas, diabetes, upper respiratory infections, fractures and falls. [ Time Frame: 5 years ]
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): NCT01052051
|United States, Nebraska|
|Fremont Area Medical Center|
|Fremont, Nebraska, United States, 68025|
|Principal Investigator:||Joan M Lappe, PhD||Creighton University|