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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01052051
Recruitment Status : Completed
First Posted : January 20, 2010
Last Update Posted : July 24, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Joan Lappe, Creighton University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer Dietary Supplement: Vitamin D3 Dietary Supplement: Calcium carbonate Phase 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Trial of Vitamin D3 to Reduce Cancer Risk in Postmenopausal Women
Study Start Date : June 2009
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Vitamin D

Arms and Interventions
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Arm Intervention/treatment
Experimental: vitamin D3 and calcium carbonate
Daily vitamin D3 2000 IU/day and calcium carbonate 1500mg/day supplementation
 Dietary Supplement: Vitamin D3
Vitamin D3 2000 IU/daily

Dietary Supplement: Calcium carbonate
Calcium carbonate 1500mg / daily
Placebo Comparator: Placebo for vitamin D3 and calcium carbonate
Placebo for daily vitamin D3 and calcium carbonate
 Dietary Supplement: Vitamin D3
Vitamin D3 2000 IU/daily

Dietary Supplement: Calcium carbonate
Calcium carbonate 1500mg / daily


Outcome Measures
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Primary Outcome Measures :
  1. all-type cancer (excluding non-melanoma skin cancers) [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. breast cancer [ Time Frame: 4 years ]
  2. colorectal cancer [ Time Frame: 4 years ]
  3. new osteoporotic fractures [ Time Frame: 4 years ]
  4. diagnosis of diabetes mellitus [ Time Frame: 4 years ]
  5. frequency and severity of asthma symptoms in persons with asthma at baseline [ Time Frame: 4 years ]
  6. frequency of falls [ Time Frame: 4 years ]
  7. frequency of colds and flu [ Time Frame: 4 years ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01052051


Locations
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United States, Nebraska
Fremont Area Medical Center
Fremont, Nebraska, United States, 68025
Sponsors and Collaborators
Creighton University
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Joan M Lappe, PhD Creighton University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Joan Lappe, Professor of Nursing and Medicine, Creighton University
ClinicalTrials.gov Identifier: NCT01052051    
Other Study ID Numbers: CAPS08-15024
R01CA129488-01A2 ( U.S. NIH Grant/Contract )
First Posted: January 20, 2010    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Vitamin D
Cholecalciferol
Calcium Carbonate
Calcium
Vitamins
Micronutrients
 Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents