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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT01052051

Run by

Creighton University

People needed

2303

Starts

2009-06-01

Expected to finish

2015-08-01

Last updated by the study team

2019-07-24

Who can join

Age: 55 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Fremont Area Medical Center — Fremont, Nebraska, United States

Full record on ClinicalTrials.gov

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