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

Creighton University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cancer

Treatments: Dietary Supplement: Calcium carbonate; Dietary Supplement: Vitamin D3

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01052051

R01CA129488-01A2 (U.S. NIH Grant/Contract)

CAPS08-15024

Details and patient eligibility

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:

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.

Enrollment: 2,303 patients

Sex: Female

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

2,303 participants in 2 patient groups, including a placebo group

vitamin D3 and calcium carbonate

Experimental group

Description:

Daily vitamin D3 2000 IU/day and calcium carbonate 1500mg/day supplementation

Treatment:

Dietary Supplement: Vitamin D3

Dietary Supplement: Calcium carbonate

Placebo for vitamin D3 and calcium carbonate

Placebo Comparator group

Description:

Placebo for daily vitamin D3 and calcium carbonate

Treatment:

Dietary Supplement: Vitamin D3

Dietary Supplement: Calcium carbonate