Clinical trial · Interventional
Clinical Trial of Vitamin D3 to Reduce Cancer Risk in Postmenopausal Women
NCT01052051CI-TRIAL-00039716CAPScompletedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calcium carbonate | Dietary Supplement | — | UNRESOLVED |
| Vitamin D3 | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- vitamin D3 and calcium carbonate
- description
- Daily vitamin D3 2000 IU/day and calcium carbonate 1500mg/day supplementation
- interventionNames
- Dietary Supplement: Vitamin D3
- Dietary Supplement: Calcium carbonate
- type
- PLACEBO_COMPARATOR
- label
- Placebo for vitamin D3 and calcium carbonate
- description
- Placebo for daily vitamin D3 and calcium carbonate
- interventionNames
- Dietary Supplement: Vitamin D3
- Dietary Supplement: Calcium carbonate
Primary outcomes (1)
- measure
- all-type cancer (excluding non-melanoma skin cancers)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 55 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLappe 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. PMID 28350929