Effect of Vitamin D and Calcium Supplementation on Cancer Incidence in Older Women: A Randomized Clinical Trial
Lappe J, Watson P, Travers-Gustafson D, Recker R, Garland C, Gorham E, Baggerly K, McDonnell SL
JAMA · 180 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Clinical events such as disease or death
Who paid for it
- Funding
- Funding not disclosed
Publication
- Published
- 2017-03-28 · JAMA · vol. 317 · issue 12 · p. 1234
- Publisher
- American Medical Association
- Cited
- 249 citations · more than 100% of similar papers · 23.9× the field average
- Impact
- Top 10% most cited in its field
- References
- 36 works
- Access
- Paywalled
- Research areas
- Vitamin D Research Studies · Vitamin C and Antioxidants Research · Cancer Risks and Factors
- Keywords
- Medicine, Vitamin D and neurology, Incidence (geometry), Calcium supplementation, Calcium, Cancer, Internal medicine, Cancer incidence, Physiology, Gerontology
- MeSH
- humans, neoplasms, osteoporosis, postmenopausal, kidney calculi, hypercalcemia, calcium, cholecalciferol, vitamins, vitamin d, incidence, proportional hazards models, double-blind method, sample size, time factors, aged, middle aged, nebraska, female, intention to treat analysis, kaplan-meier estimate
8 authors
From US
- Joan M. Lappe · correspondingCreighton University
- Patrice A. WatsonCreighton University
- Dianne Travers‐GustafsonCreighton University
- Robert R. ReckerCreighton University
- Cedric F. GarlandUniversity of California San Diego
- Edward Doerr GorhamUniversity of California San Diego
Abstract
Importance
Evidence suggests that low vitamin D status may increase the risk of cancer.
Objective
To determine if dietary supplementation with vitamin D3 and calcium reduces the risk of cancer among older women.
Design, setting, and participants
A 4-year, double-blind, placebo-controlled, population-based randomized clinical trial in 31 rural counties (June 24, 2009, to August 26, 2015-the final date of follow-up). A total of 2303 healthy postmenopausal women 55 years or older were randomized, 1156 to the treatment group and 1147 to the placebo group. Duration of treatment was 4 years.
Interventions
The treatment group (vitamin D3 + calcium group) received 2000 IU/d of vitamin D3 and 1500 mg/d of calcium; the placebo group received identical placebos.
Main outcomes and measures
The primary outcome was the incidence of all-type cancer (excluding nonmelanoma skin cancers), which was evaluated using Kaplan-Meier survival analysis and proportional hazards modeling.
Results
Among 2303 randomized women (mean age, 65.2 years [SD, 7.0]; mean baseline serum 25-hydroxyvitamin D level, 32.8 ng/mL [SD, 10.5]), 2064 (90%) completed the study. At year 1, serum 25-hydroxyvitamin D levels were 43.9 ng/mL in the vitamin D3 + calcium group and 31.6 ng/mL in the placebo group. A new diagnosis of cancer was confirmed in 109 participants, 45 (3.89%) in the vitamin D3 + calcium group and 64 (5.58%) in the placebo group (difference, 1.69% [95% CI, -0.06% to 3.46%]; P = .06). Kaplan-Meier incidence over 4 years was 0.042 (95% CI, 0.032 to 0.056) in the vitamin D3 + calcium group and 0.060 (95% CI, 0.048 to 0.076) in the placebo group; P = .06. In unadjusted Cox proportional hazards regression, the hazard ratio was 0.70 (95% CI, 0.47 to 1.02). Adverse events potentially related to the study included renal calculi (16 participants in the vitamin D3 + calcium group and 10 in the placebo group), and elevated serum calcium levels (6 in the vitamin D3 + calcium group and 2 in the placebo group).
Conclusions and relevance
Among healthy postmenopausal older women with a mean baseline serum 25-hydroxyvitamin D level of 32.8 ng/mL, supplementation with vitamin D3 and calcium compared with placebo did not result in a significantly lower risk of all-type cancer at 4 years. Further research is necessary to assess the possible role of vitamin D in cancer prevention.
Trial registration
clinicaltrials.gov Identifier: NCT01052051.
Abstract via Europe PMC. Copyright remains with the authors or publisher.
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