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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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. Specific Aims: 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.

Official Title
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Clinical Trial of Vitamin D3 to Reduce Cancer Risk in Postmenopausal Women

Conditions
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Cancer

Intervention / Treatment
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* Dietary Supplement: Vitamin D3
* Dietary Supplement: Calcium carbonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: ≥ 55 years Last menstrual period (LMP): ≥ 4 years Good general health Willingness to participate in this 4 year long study Able to give informed consent Able to live independently and travel to the Fremont Area Medical Center (FAMC) for study visits Exclusion Criteria: History of cancer except Superficial basal or squamous cell carcinoma of the skin Other malignancies treated curatively more than 10 years ago History of renal calculi or chronic kidney disease History of sarcoidosis History of tuberculosis Participation in the previous Creighton cancer prevention study Mini-Mental Status Exam (MMSE) score of ≤ 23. Use the MMSE if there are any concerns about the person's cognitive abilities or ability to give fully informed consent to the study. Concerns may be related to a person's lack of orientation to person, place, or time; language difficulties (inability to structure simple, complete sentences); or short term memory. The Hartford Institute for Geriatric Nursing recommends that a score of 23 or lower indicates cognitive impairment. (Accessed at www.harforddign.org). See appendix.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin D3 and calcium carbonate<br>Daily vitamin D3 2000 IU/day and calcium carbonate 1500mg/day supplementation | Dietary Supplement: Vitamin D3<br>* Vitamin D3 2000 IU/daily<br>Dietary Supplement: Calcium carbonate<br>* Calcium carbonate 1500mg / daily<br>|
| Placebo Comparator: Placebo for vitamin D3 and calcium carbonate<br>Placebo for daily vitamin D3 and calcium carbonate | Dietary Supplement: Vitamin D3<br>* Vitamin D3 2000 IU/daily<br>Dietary Supplement: Calcium carbonate<br>* Calcium carbonate 1500mg / daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-type cancer (excluding non-melanoma skin cancers) |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| breast cancer |  | 4 years | 
| colorectal cancer |  | 4 years | 
| new osteoporotic fractures |  | 4 years | 
| diagnosis of diabetes mellitus |  | 4 years | 
| frequency and severity of asthma symptoms in persons with asthma at baseline |  | 4 years | 
| frequency of falls |  | 4 years | 
| frequency of colds and flu |  | 4 years |