Influence of vitamin D supplementation on fracture risk, bone mineral density and bone biochemistry in Mongolian schoolchildren: multicenter double-blind randomized placebo-controlled trial.

Autor: Ganmaa D; Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.; Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA., Khudyakov P; Sage Therapeutics, Cambridge, MA, USA., Buyanjargal U; Mongolian Health Initiative, Royal Plaza, Bayanzurkh District, Ulaanbaatar 13312, Mongolia., Tserenkhuu E; Global Laboratory, Royal Plaza, Bayanzurkh District, Ulaanbaatar 13312, Mongolia., Erdenenbaatar S; Mongolian Health Initiative, Royal Plaza, Bayanzurkh District, Ulaanbaatar 13312, Mongolia., Achtai CE; Mongolian Health Initiative, Royal Plaza, Bayanzurkh District, Ulaanbaatar 13312, Mongolia., Yansan N; Mongolian Health Initiative, Royal Plaza, Bayanzurkh District, Ulaanbaatar 13312, Mongolia., Delgererekh B; Global Laboratory, Royal Plaza, Bayanzurkh District, Ulaanbaatar 13312, Mongolia., Ankhbat M; Global Laboratory, Royal Plaza, Bayanzurkh District, Ulaanbaatar 13312, Mongolia., Tsendjav E; Mongolian Health Initiative, Royal Plaza, Bayanzurkh District, Ulaanbaatar 13312, Mongolia., Ochirbat B; National Center for Communicable Disease, Bayanzurkh District, Ulaanbaatar 13312, Mongolia., Jargalsaikhan B; Mongolian National University of Medical Sciences, Sukhbaatar District, Ulaanbaatar 14210, Mongolia., Davaasambuu E; National Center for Maternal and Child Health, Bayangol District, Ulaanbaatar 16060, Mongolia., Martineau AR; Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, UK.
Jazyk: angličtina
Zdroj: MedRxiv : the preprint server for health sciences [medRxiv] 2023 May 19. Date of Electronic Publication: 2023 May 19.
DOI: 10.1101/2023.05.18.23290181
Abstrakt: Background: Randomized controlled trials (RCT) of vitamin D supplementation to reduce fracture risk in children are lacking.
Methods: We conducted a Phase 3 RCT of weekly oral supplementation with 14,000 IU vitamin D 3 for 3 years in Mongolian schoolchildren aged 6-13 years. Serum 25-hydroxyvitamin D (25[OH]D) concentrations and the proportion of participants reporting ≥1 fracture were secondary outcomes for the main trial. Radial bone mineral density (BMD) was assessed in a nested sub-study, with serum concentrations of parathyroid hormone (PTH) and bone-specific alkaline phosphatase (BALP) determined in a subset of participants.
Findings: 8851 children were enrolled in the main trial, of whom 1465 also participated in the sub-study. Vitamin D deficiency was prevalent at baseline (25[OH]D <20 ng/mL in 90.1%). The intervention elevated 25(OH)D concentrations (adjusted inter-arm mean difference [aMD] 20.3 ng/mL, 95% CI 19.9 to 20.6) and suppressed PTH concentrations (aMD -13.6 pmol/L, 95% CI -23.5 to -3.7), but it did not influence fracture risk (adjusted risk ratio 1.10, 95% CI 0.93 to 1.29, P=0.27) or radial BMD z-score (aMD -0.06, 95% CI -0.18 to 0.07, P=0.36). Vitamin D suppressed serum BALP concentrations more among participants with baseline 25(OH)D concentrations <10 vs. ≥10 ng/mL (P interaction =0.04). However, effects of the intervention on fracture risk and radial BMD were not modified by baseline vitamin D status (P interaction ≥0.67).
Interpretation: Weekly oral vitamin D supplementation elevated serum 25(OH)D concentrations and suppressed PTH concentrations in vitamin D-deficient schoolchildren in Mongolia. However, this was not associated with reduced fracture risk or increased radial BMD.
Funding: National Institutes of Health.
Competing Interests: DECLARATION OF INTERESTS ARM declares receipt of funding in the last 36 months to support vitamin D research from the following companies who manufacture or sell vitamin D supplements: Pharma Nord Ltd, DSM Nutritional Products Ltd, Thornton & Ross Ltd and Hyphens Pharma Ltd. ARM also declares receipt of vitamin D capsules for clinical trial use from Pharma Nord Ltd, Synergy Biologics Ltd and Cytoplan Ltd; support for attending meetings from Pharma Nord Ltd and Abiogen Pharma Ltd; receipt of consultancy fees from DSM Nutritional Products Ltd and Qiagen Ltd; receipt of a speaker fee from the Linus Pauling Institute; participation on Data and Safety Monitoring Boards for the VITALITY trial (Vitamin D for Adolescents with HIV to reduce musculoskeletal morbidity and immunopathology, Pan African Clinical Trials Registry ref PACTR20200989766029) and the Trial of Vitamin D and Zinc Supplementation for Improving Treatment Outcomes Among COVID-19 Patients in India (ClinicalTrials.gov ref NCT04641195); and unpaid work as a Programme Committee member for the Vitamin D Workshop. All other authors declare that they have no competing interests.
Databáze: MEDLINE
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