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From: trigonometry1972 on 21 Jun 2008 15:31 Clin Endocrinol Metab. 2008 Apr 29. [Epub ahead of print] SHORT-TERM AND LONG-TERM SAFETY OF WEEKLY HIGH-DOSE VITAMIN D3 SUPPLEMENTATION IN SCHOOL CHILDREN. Maalouf J, Nabulsi M, Vieth R, Kimball S, El-Rassi R, Mahfoud Z, El-Hajj Fuleihan G. 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. 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. PMID: 18445674 |