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

Cancer Clinical Trial

— CAPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01052051
• Other study ID #: CAPS08-15024
• Secondary ID: R01CA129488-01A2
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 2009
• Est. completion date: August 2015

Study information

• Verified date: July 2019
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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:

1. Increasing serum 25(OH)D 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2303
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Dietary Supplement:
• Vitamin D3
Vitamin D3 2000 IU/daily
• Calcium carbonate
Calcium carbonate 1500mg / daily

Locations

Country	Name	City	State
United States	Fremont Area Medical Center	Fremont	Nebraska

Sponsors (3)

Lead Sponsor	Collaborator
Creighton University	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-type cancer (excluding non-melanoma skin cancers)		4 years
Secondary	breast cancer		4 years
Secondary	colorectal cancer		4 years
Secondary	new osteoporotic fractures		4 years
Secondary	diagnosis of diabetes mellitus		4 years
Secondary	frequency and severity of asthma symptoms in persons with asthma at baseline		4 years
Secondary	frequency of falls		4 years
Secondary	frequency of colds and flu		4 years