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This version published online on April 29, 2008
Journal of Clinical Endocrinology & Metabolism, doi:10.1210/jc.2007-2530
A more recent version of this article appeared on July 1, 2008
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Submitted on November 14, 2007
Accepted on April 18, 2008

SHORT-TERM AND LONG-TERM SAFETY OF WEEKLY HIGH-DOSE VITAMIN D3 SUPPLEMENTATION IN SCHOOL CHILDREN

Joyce Maalouf, Mona Nabulsi, Reinhold Vieth, Samantha Kimball, Rola El-Rassi, Ziyad Mahfoud, and Ghada El-Hajj Fuleihan*

Calcium Metabolism and Osteoporosis Program, Department of Internal Medicine, Department of Pediatrics, School of Medicine, American University of Beirut, Beirut, Lebanon; Department of Nutritional Sciences, Department of Laboratory Medicine, University of Toronto, Toronto, Canada; Department of Epidemiology and Population Health, School of Health Sciences, American University of Beirut, Beirut, Lebanon

* To whom correspondence should be addressed. E-mail: gf01{at}aub.edu.lb.

Background: Hypovitaminosis D is prevalent in youth worldwide, but the safety of vitamin D at doses exceeding 200 IU/day is unknown in this age group. We assessed the safety of high doses of vitamin D3 administered to apparently healthy school children.

Methods: short term safety: 25 subjects randomly received placebo or vitamin D3 at doses of 14,000 IU/wk for 8 weeks. Long term safety: 340 subjects randomly received placebo, vitamin D3 as 1400 IU or 14,000 IU/week for one year. Biochemical variables were monitored at 0, 2, 4, 6, 8 weeks, and 8 weeks off therapy in the short term study and at 0, 6 and 12 months in the long term study.

Results: In both the short term and long term studies, mean serum calcium and 1,25-OHD levels did not change in any group. In the short term study, mean 25-OHD concentrations increased from 44 (± 11) ng/ml to 54 (± 19) ng/ml in the treated groups (P=0.033). In the long term study, mean 25-OHD levels increased from 15±8 to 19±7 ng/ml (p<0.0001) in subjects receiving 1400 IU/wk; and from 15±7 to 36±22ng/ml in the group receiving 14,000 IU/wk (p<0.0001). No subject developed vitamin D intoxication.

Conclusion: Vitamin D3 at doses equivalent to 2,000 IU/day for one year is safe in adolescents and results in desirable vitamin D levels.
Key words: safety • recommendations • daily allowance • hypovitaminosis D • children






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