Clinical trial NCT01052051: Clinical Trial of Vitamin D3 to Reduce Cancer Risk in Postmenopausal Women
Official title: Clinical Trial of Vitamin D3 to Reduce Cancer Risk in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cancer
Lead sponsor: Creighton University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2010-01-20
Enrollment: 2303
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: all-type cancer (excluding non-melanoma skin cancers)
timeFrame: 4 years
Secondary outcomes:
measure: breast cancer
timeFrame: 4 years
measure: colorectal cancer
timeFrame: 4 years
measure: new osteoporotic fractures
timeFrame: 4 years
measure: diagnosis of diabetes mellitus
timeFrame: 4 years
measure: frequency and severity of asthma symptoms in persons with asthma at baseline
timeFrame: 4 years
measure: frequency of falls
timeFrame: 4 years
measure: frequency of colds and flu
timeFrame: 4 years
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Fremont Area Medical Center
state: Nebraska
Study officials:
affiliation: Creighton University
name: Joan M Lappe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lappe J, Watson P, Travers-Gustafson D, Recker R, Garland C, Gorham E, Baggerly K, McDonnell SL. Effect of Vitamin D and Calcium Supplementation on Cancer Incidence in Older Women: A Randomized Clinical Trial. JAMA. 2017 Mar 28;317(12):1234-1243. doi: 10.1001/jama.2017.2115.