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Vitamin D Supplementation and Fracture Incidence in Elderly Persons: A Randomized, Placebo-Controlled Clinical Trial

Paul Lips, MD; Wilco C. Graafmans, MS; Marcel E. Ooms, MD; P. Dick Bezemer, PhD; and Lex M. Bouter, PhD
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From Vrije Universiteit, Amsterdam, the Netherlands. Acknowledgments: The authors thank the many persons who contributed to this study, especially Mrs. Nel van der Kreeke, Els Lommerse-Rusman, Saskia van Bennekom, Madeleine de Boer, and Andries Tahapary for invaluable organizational help; Drs. Ronald ter Schegget, Didy Kriegsman, and Nico de Neeling for their help in the start-up phase of the study; Dr. Wim J. van der Vijgh and Simon Velt for the measurement of 25-hydroxyvitamin D; Hans Wagemaker for the randomization of the tablets; Dr. W. Ezechiels and other general practitioners for their help; staff and personnel of the participating homes for the elderly for their assistance; and Drs. Olli Miettinen and Hans Valkenburg for advice in designing the study. Grant Support: In part by the Praeventiefonds, the Hague, the Netherlands (grant 28-1112-1). Vitamin D and placebo tablets were provided by Solvay-Duphar, Inc., Weesp, the Netherlands. Requests for Reprints: Paul Lips, MD, Department of Endocrinology, Academisch Ziekenhuis Vrije Universiteit, PO Box 7057, 1007 MB Amsterdam, the Netherlands. Current Author Addresses: Dr. Lips: Department of Endocrinology, Academisch Ziekenhuis Vrije Universiteit, PO Box 7057, 1007 MB Amsterdam, the Netherlands.


Copyright ©2004 by the American College of Physicians


Ann Intern Med. 1996;124(4):400-406. doi:10.7326/0003-4819-124-4-199602150-00003
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Objective: To determine whether vitamin D supplementation decreases the incidence of hip fractures and other peripheral bone fractures.

Design: Prospective, double-blind trial.

Setting: Community setting (Amsterdam and surrounding area).

Patients: 2578 persons (1916 women, 662 men) 70 years of age and older (mean age ±SD, 80 ± 6 years) living independently, in apartments for elderly persons, or in homes for elderly persons.

Intervention: Participants were randomly assigned to receive either vitamin D3, 400 IU in one tablet daily, or placebo for a maximum of 3.5 years.

Measurements: Dietary calcium intake and serum 25-hydroxyvitamin D [25(OH)D] were estimated in a subset of participants. During follow-up, attention was concentrated on hip fractures and other peripheral fractures. The maximal follow-up period was 4 years. The results were evaluated by survival analysis.

Results: Mean dietary calcium intake from dairy products was 868 mg/d. Mean serum 25(OH)D concentration in the third year of the study was 23 nmol/L in the placebo group and 60 nmol/L in the vitamin D group. Median follow-up was 3.5 years, and total follow-up was 8450 patient-years. During follow-up, 306 persons in the placebo group and 282 persons in the vitamin D group died (P = 0.20). Hip fractures occurred in 48 persons in the placebo group and 58 persons in the vitamin D group (P = 0.39, intention-to-treat analysis). Other peripheral fractures occurred in 74 persons in the placebo group and 77 persons in the vitamin D group (P = 0.86).

Conclusion: Our results do not show a decrease in the incidence of hip fractures and other peripheral fractures in Dutch elderly persons after vitamin D supplementation.

Figures

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Figure 1.
Cumulative proportion of participants with first hip fracture (Kaplan-Meier method) in the placebo group (X) and the group assigned to receive vitamin D3 treatment (•). Top.Bottom.

According to intention-to-treat analysis. According to active treatment analysis.

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