Vitamin D supplements for fracture prevention in schoolchildren in Mongolia: analysis of secondary outcomes from a multicentre, double-blind, randomised, placebo-controlled trial.

Autor:	Ganmaa D; Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; Department of Nutrition, Harvard T H Chan School of Public Health, Boston, MA, USA. Electronic address: gdavaasa@hsph.harvard.edu., Khudyakov P; Sage Therapeutics, Cambridge, MA, USA., Buyanjargal U; Mongolian Health Initiative, Ulaanbaatar, Mongolia., Tserenkhuu E; Global Laboratory, Ulaanbaatar, Mongolia., Erdenenbaatar S; Mongolian Health Initiative, Ulaanbaatar, Mongolia., Achtai CE; Mongolian Health Initiative, Ulaanbaatar, Mongolia., Yansanjav N; Mongolian Health Initiative, Ulaanbaatar, Mongolia., Delgererekh B; Global Laboratory, Ulaanbaatar, Mongolia., Ankhbat M; Global Laboratory, Ulaanbaatar, Mongolia., Tsendjav E; Mongolian Health Initiative, Ulaanbaatar, Mongolia., Ochirbat B; National Center for Communicable Disease, Ulaanbaatar, Mongolia., Jargalsaikhan B; Mongolian National University of Medical Sciences, Ulaanbaatar, Mongolia., Enkhmaa D; National Center for Maternal and Child Health, Ulaanbaatar, Mongolia., Martineau AR; Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK. Electronic address: a.martineau@qmul.ac.uk.
Jazyk:	angličtina
Zdroj:	The lancet. Diabetes & endocrinology [Lancet Diabetes Endocrinol] 2024 Jan; Vol. 12 (1), pp. 29-38. Date of Electronic Publication: 2023 Dec 01.
DOI:	10.1016/S2213-8587(23)00317-0
Abstrakt:	Background: Vitamin D supplementation has been shown to increase total hip areal bone mineral density in healthy children and adolescents. We aimed to investigate whether supplementing schoolchildren living in Mongolia with weekly vitamin D 3 for 3 years affected fracture risk. Methods: We did a multicentre, double-blind, randomised, placebo-controlled trial across 18 public schools in Ulaanbaatar, Mongolia. Schoolchildren were eligible if they were aged 6-13 years at screening, had a negative QuantiFERON-TB Gold In-tube assay (QFT) result, were not hypersensitive to vitamin D or immunocompromised, did not use vitamin D supplements, did not have clinical signs of rickets, and had no intention of leaving Ulaanbaatar within 3 years. Participants were randomly assigned (1:1) to receive either vitamin D (oral dose of 14 000 international units [IU] vitamin D 3 , once per week) or placebo for 3 years using permuted block randomisation stratified by school of attendance. Participants, care providers, and all trial staff were masked to group assignment during the intervention. Prespecified secondary outcomes were incidence of fractures and adverse events, ascertained using questionnaires. The fracture and safety analyses included participants who completed at least one follow-up fracture questionnaire. We estimated adjusted risk ratios (RRs) and 95% CIs using generalised linear models with binomial distribution and a log link function with adjustment for school of attendance. The trial is registered with ClinicalTrials.gov, NCT02276755, and the intervention ended in May, 2019. Findings: Between Sept 2, 2015, and March 20, 2017, 11 475 children were invited to participate in the study and 8851 were recruited and randomly assigned to receive either vitamin D (n=4418) or placebo (n=4433). 8348 participants were included in the fracture and safety analyses (4176 [94·5%] in the vitamin D group and 4172 [94·1%] in the placebo group). Of these, 4125 (49·4%) were female, 4223 (50·6%) were male, and 7701 (92·2%) were of Khalkh ancestry. Median age was 9·2 years (IQR 8·0-10·7) and 7975 (95·5%) participants had baseline serum 25-hydroxyvitamin D concentrations less than 50 nmol/L. During a median follow-up of 3·0 years (IQR 2·9-3·1), 268 (6·4%) participants in the vitamin D group and 253 (6·1%) in the placebo group reported one or more fractures (adjusted RR 1·10, 95% CI 0·93-1·29; p=0·27). Incidence of adverse events did not differ between study groups. Interpretation: Oral vitamin D supplementation at a dose of 14 000 IU/week for 3 years was safe, but did not influence fracture risk in schoolchildren living in Mongolia who had a high baseline prevalence of vitamin D deficiency. Funding: US National Institutes of Health. Competing Interests: Declaration of interests ARM declares receipt of funding to support vitamin D research from Pharma Nord, DSM Nutritional Products, Thornton & Ross, and Hyphens Pharma. ARM also declares receipt of vitamin D capsules for clinical trial use from Pharma Nord, Synergy Biologics, and Cytoplan; support for attending meetings from Pharma Nord and Abiogen Pharma; receipt of consultancy fees from DSM Nutritional Products and Qiagen; receipt of a speaker fee from the Linus Pauling Institute (Corvallis, OR, USA); participation on data and safety monitoring boards for the VITALITY trial (PACTR20200989766029) and the trial of Vitamin D and Zinc Supplementation for Improving Treatment Outcomes Among COVID-19 Patients in India (NCT04641195); and unpaid work as a programme committee member for the Vitamin D Workshop. All other authors declare no competing interests. (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)
Databáze:	MEDLINE
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