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1600 IU vitamin D safe for infants – RCT Nov 2102

High-Dose Vitamin D Intervention in Infants—Effects on Vitamin D Status, Calcium Homeostasis, and Bone Strength

The Journal of Clinical Endocrinology & Metabolism November 1, 2012 vol. 97 no. 11 4139-4147
Elisa Holmlund-Suila,
Heli Viljakainen,
Timo Hytinantti,
Christel Lamberg-Allardt,
Sture Andersson and
Outi Mäkitie
Children's Hospital (E.H.-S., H.V., S.A., O.M.), University of Helsinki and Helsinki University Central Hospital, 00029 Helsinki, Finland; Helsinki Maternity Hospital (T.H.), 00029 Helsinki, Finland; Calcium Research Unit (C.L.-A.), Department of Food and Environmental Sciences (Nutrition), University of Helsinki, 00014 Helsinki, Finland; and Folkhälsan Research Center (O.M.), 00014 Helsinki, Finland

Address all correspondence and requests for reprints to: Dr. Outi Mäkitie, Pediatric Endocrinology and Metabolic Bone Diseases, Children's Hospital, Helsinki University Central Hospital and University of Helsinki, P.O. Box 281, FIN-00029 HUS, Helsinki, Finland. E-mail: outi.makitie at helsinki.fi.

Context: Guidelines in Finland recommend 10 μg of vitamin D3 daily for all infants. Recent observations suggest that this may be insufficient to maintain optimal serum 25-hydroxyvitamin D (S-25-OHD).

Objective: The aim of the study was to evaluate effects of various vitamin D doses and determine a dose ensuring S-25-OHD of at least 80 nmol/liter in infants without signs of vitamin D excess.

Design: We conducted a randomized double-blind intervention study. Cord blood was obtained at birth for S-25-OHD; 113 infants were randomized to receive vitamin D3 10, 30, or 40 μg/d from age 2 wk to 3 months.

Setting: An investigator-initiated study was performed in a single maternity hospital in Helsinki, Finland.

Main Outcome Measures: S-25-OHD, calcium homeostasis, and skeletal characteristics were evaluated with peripheral quantitative computed tomography at age 3 months.

Results: Baseline S-25-OHD was similar in all three groups (median, 53 nmol/liter). At 3 months, the mean S-25-OHD values were 88, 124, and 153 nmol/liter, and the minimum values were 46, 57, and 86 nmol/liter in the groups receiving 10, 30, and 40 μg (ANOVA; P < 0.001). No hypercalcemia occurred; plasma calcium, serum PTH, and urine calcium excretion was similar between the groups. Peripheral quantitative computed tomography showed a trend toward larger tibial total bone and cortical bone area with higher vitamin D doses.

Conclusion: Vitamin D3 supplementation with up to 40 μg/d from age 2 wk to 3 months was safe and caused no hypercalcemia or hypercalciuria.
The 40-μg dose maintained S-25-OHD above 80 nmol/liter in all infants.
More extensive and longer intervention studies are necessary to assess long-term effects.


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See also VitaminDWiki

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