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About
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.
Full 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:
Specific Aims:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
History of cancer except
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.
Primary purpose
Allocation
Interventional model
Masking
2,303 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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