New York Times reporting on NEJM study
- "But now, in the first large randomized controlled study in the United States, funded by the federal government, researchers report that vitamin D pills taken with or without calcium have no effect on bone fracture rates."
NO Calcium was used in the trial - yet NYT said otherwise
Half of participants had sufficient Vitamin D
Many were likely taking 800 IU daily (intervention group also took 2,000 IU)
NEJM sub-study of VITAL - July 2022
Supplemental Vitamin D and Incident Fractures in Midlife and Older Adults
N Engl J Med 2022; 387:299-309 July 28, 2022 DOI: 10.1056/NEJMoa2202106
Meryl S. LeBoff, M.D., Sharon H. Chou, M.D., Kristin A. Ratliff, B.A., Nancy R. Cook, Sc.D., Bharti Khurana, M.D., Eunjung Kim, M.S., Peggy M. Cawthon, Ph.D., M.P.H., Douglas C. Bauer, M.D., Dennis Black, Ph.D., J. Chris Gallagher, M.D., I-Min Lee, M.B., B.S., Sc.D., Julie E. Buring, Sc.D., et al.
BACKGROUND
Vitamin D supplements are widely recommended for bone health in the general population, but data on whether they prevent fractures have been inconsistent.
METHODS
In an ancillary study of the Vitamin D and Omega-3 Trial (VITAL), we tested whether supplemental vitamin D3 would result in a lower risk of fractures than placebo. VITAL was a two-by-two factorial, randomized, controlled trial that investigated whether supplemental vitamin D3 (2000 IU per day), n−3 fatty acids (1 g per day), or both would prevent cancer and cardiovascular disease in men 50 years of age or older and women 55 years of age or older in the United States. Participants were not recruited on the basis of vitamin D deficiency, low bone mass, or osteoporosis. Incident fractures were reported by participants on annual questionnaires and adjudicated by centralized medical-record review. The primary end points were incident total, nonvertebral, and hip fractures. Proportional-hazards models were used to estimate the treatment effect in intention-to-treat analyses.
RESULTS
Among 25,871 participants (50.6% women [13,085 of 25,871] and 20.2% Black [5106 of 25,304]), we confirmed 1991 incident fractures in 1551 participants over a median follow-up of 5.3 years. Supplemental vitamin D3, as compared with placebo, did not have a significant effect on total fractures (which occurred in 769 of 12,927 participants in the vitamin D group and in 782 of 12,944 participants in the placebo group; hazard ratio, 0.98; 95% confidence interval [CI], 0.89 to 1.08; P=0.70), nonvertebral fractures (hazard ratio, 0.97; 95% CI, 0.87 to 1.07; P=0.50), or hip fractures (hazard ratio, 1.01; 95% CI, 0.70 to 1.47; P=0.96). There was no modification of the treatment effect according to baseline characteristics, including age, sex, race or ethnic group, body-mass index, or serum 25-hydroxyvitamin D levels. There were no substantial between-group differences in adverse events as assessed in the parent trial.
CONCLUSIONS
Vitamin D3 supplementation did not result in a significantly lower risk of fractures than placebo among generally healthy midlife and older adults who were not selected for vitamin D deficiency, low bone mass, or osteoporosis. (Funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases; VITAL ClinicalTrials.gov number, NCT01704859. opens in new tab.)
VITAL did not use Calcium nor exercise needed to build bones
- Increased risk of fracture if high level of Vitamin D (if continue to take Calcium) – umbrella analysis of meta-analyses Nov 2020
- Vitamin D not help fractures and falls if not vitamin D deficient – meta-analysis Oct 2018
- Fractures reduced with any amount of vitamin D and some Calcium - Cochraine April 2014
- A call to action: Vitamin D for hip fracture (50,000 weekly for 8 weeks, then bi-weekly – Holick July 2020
- 1 in 3 died after hip fracture but only 1 in 14 if add Vitamin D and exercise – RCT April 2017
- Silicon, Vitamin D and Bone Health - multiple studies
NEJM Editorial in the same issue
- “Providers should stop screening for 25-hydroxyvitamin D levels or recommending vitamin D supplements and people should stop taking vitamin D supplements in order to prevent major diseases or extend life,”
- "And Dr. Rosen, who signed off on the National Academy of Medicine report, has become a vitamin D therapeutic nihilist. “I don’t believe any more in 600 units,” he said. “I don’t believe you should do anything.”
VitaminDWiki - Falls and Fractures category contains
254 items in FALLS and FRACTURES - Vitamin D and Calcium cost-effectively reduce falls and fractures – April 2019
- see also Overview Seniors and Vitamin D
Falls
- Fall prevention - Vitamin D is one of the ways - umbrella review Jan 2024
- Deaths due to falls doubled in just a decade (age-adjusted, perhaps decreased vitamin D) – June 2019
- Preventing Falls in Older Adults – Vitamin D combination is the best - JAMA Meta-analysis Nov 2017
- Falls cut in half by 100,000 IU vitamin D monthly - RCT 2016
- Falls reduced by a third if achieved 40 ng level vitamin D– RCT Sept 2018
- Note: It took 6 months to get to that level. Most trials last only 3 months
- Vitamin D prevents falls – majority of meta-analyses conclude – meta-meta analysis Feb 2015
- Falls reduced by Vitamin D: 13 percent reduction if more than 700 IU – review of 38 trials – Aug 2022
Fracture
- Hip fractures are predicted by 10 factors – low Vitamin D is the biggest – Aug 2023
- Vitamin D and fractures – 24 meta-analyses and counting – Dec 2014
- Low trauma bone fractures in seniors – considering Vitamin D loading dose for all, without testing – Nov 2019
- Vitamin K (any amount and any kind) reduced bone fractures by 24 percent – meta-analysis – May 2019
- 75+ Hip fracture items in VitaminDWiki title Click here for details
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