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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Joan Lappe, Creighton University
ClinicalTrials.gov Identifier:
NCT01052051
First received: January 19, 2010
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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

The purpose of this study is to determine if vitamin D3 and calcium supplementation decreases the risk of developing cancer.


Condition Intervention Phase
Cancer
Dietary Supplement: Vitamin D
Dietary Supplement: Calcium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Trial of Vitamin D3 to Reduce Cancer Risk in Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • The primary outcome measure will be a cancer diagnosis. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine whether the achieved level of serum 25OHD at the end of year one of study predicts risk of cancer over four years [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The secondary outcome will be cancer diagnosis.

  • The secondary outcomes will be: 1. cancers: breast, lung, colon, myeloma, leukemia, lymphoma and 2. hypertension, cardiovascular disease, osteoarthritis, colonic adenomas, diabetes, upper respiratory infections, fractures and falls. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2300
Study Start Date: June 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: calcium
Daily calcium supplementation
Dietary Supplement: Calcium
Calcium 1200mg / daily
Experimental: Vitamin D
Daily Calcium and Vitamin D supplementation
Dietary Supplement: Vitamin D
Vitamin D 2000 IU/daily

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   55 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052051

Locations
United States, Nebraska
Fremont Area Medical Center
Fremont, Nebraska, United States, 68025
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Joan M Lappe, PhD Creighton University
  More Information

No publications provided

Responsible Party: Joan Lappe, Professor of Medicine, Creighton University
ClinicalTrials.gov Identifier: NCT01052051     History of Changes
Other Study ID Numbers: CAPS08-15024, R01CA129488-01A2
Study First Received: January 19, 2010
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Vitamins
Vitamin D
Ergocalciferols
Calcium, Dietary
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 30, 2014