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


Phase 3
55 Years
N/A
Open (Enrolling)
Female
Cancer

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Trial Information

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


Hypotheses:

Primary: Increasing serum 25OHD from prevailing levels will significantly decrease
incidence of all types of cancer combined in a population sample of healthy postmenopausal
women.

Secondary:

1. Increasing serum 25OHD 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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

The primary outcome measure will be a cancer diagnosis.

Outcome Time Frame:

5 years

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

CAPS08-15024

NCT ID:

NCT01052051

Start Date:

June 2009

Completion Date:

June 2015

Related Keywords:

  • Cancer

Name

Location

Fremont Area Medical CenterFremont, Nebraska  68025-2387