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Administration of High-Dose Vitamin D to Prevent Fractures
Source: Trivedi DP, et al. Effect of four monthly oral vitamin D3 (cholecalciferol) supplementation on fractures and mortality in men and women living in the community: Randomised double blind controlled trial. BMJ 2003;326:469.
Goal: To determine whether the use of high-dose vitamin D administered every four months would have a positive effect on fracture risk and all-cause mortality.
Design: Randomized, double-blind, placebo-controlled pilot trial performed over five years.
Subjects: A total of 2,686 men and women ages 65-85 years recruited from British physician registers (2,037 men, 649 women).
Methods: Subjects were randomized to receive by mail, and then immediately take, either 100,000 IU of cholecalcif-erol or a matching placebo every four months for a total of five years.
Upon receipt of the capsules, participants were also to fill out forms listing medical events, including fractures.
Four years into the study a modified food frequency questionnaire was employed to estimate dietary calcium intake, and 235 subjects were invited to have serum parathyroid hormone and vitamin D concentrations determined.
Results: Differences appeared one year into the study. A lower fracture rate was found in the vitamin D-treated group as compared with placebo (22% lower rate for first fracture regardless of site, and 33% lower rate for fractures at major osteoporotic sites including the hip, wrist, forearm, and vertebrae).
A lower rate of all-cause mortality found in the vitamin D-treated group did not reach statistical significance. Mean vitamin D concentrations were 40% higher in those who received the active treatment.
Conclusion: A dose of 100,000 IU of vitamin D administered orally in an every-four-month schedule helps prevent fractures in people older than age 65.
Study strengths: Minimal exclusion criteria (generalizable); good compliance with protocol.
Study weaknesses: Majority of data obtained was self-reported by participants; inherent weaknesses associated with food frequency questionnaires.
Of note: The every-four-month dosage schedule of 100,000 IU vitamin D is equivalent to a daily dose of 800 IU vitamin D. Also, parathyroid hormone levels were not affected significantly with the dosage regimen studied in this trial. No adverse effects were reported.
We knew that: The majority of fracture prevention trials have focused on women with osteoporosis or previous fractures.
Clinical import: The conclusions of this well-done pilot trial strongly suggest that a high-dose regimen of vitamin D offered on a schedule that promotes compliance (once every four months) can significantly lessen fracture risk in older adults. Keeping in mind the graying of the population and the well- recognized complications associated with fractures in the elderly, such an intervention could have widespread health benefits—across socioeconomic boundaries.
What to do with this article: Keep a hard copy in your file cabinet.