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Importance: Severe asthma exacerbations cause significant morbidity and costs. Whether vitamin D3 supplementation reduces severe childhood asthma exacerbations is unclear.
Objective: To determine whether vitamin D3 supplementation improves the time to a severe exacerbation in children with asthma and low vitamin D levels.
Design, Setting, And Participants: The Vitamin D to Prevent Severe Asthma Exacerbations (VDKA) Study was a randomized, double-blind, placebo-controlled clinical trial of vitamin D3 supplementation to improve the time to severe exacerbations in high-risk children with asthma aged 6 to 16 years taking low-dose inhaled corticosteroids and with serum 25-hydroxyvitamin D levels less than 30 ng/mL. Participants were recruited from 7 US centers. Enrollment started in February 2016, with a goal of 400 participants; the trial was terminated early (March 2019) due to futility, and follow-up ended in September 2019.
Interventions: Participants were randomized to vitamin D3, 4000 IU/d (n = 96), or placebo (n = 96) for 48 weeks and maintained with fluticasone propionate, 176 μg/d (6-11 years old), or 220 μg/d (12-16 years old).
Main Outcomes And Measures: The primary outcome was the time to a severe asthma exacerbation. Secondary outcomes included the time to a viral-induced severe exacerbation, the proportion of participants in whom the dose of inhaled corticosteroid was reduced halfway through the trial, and the cumulative fluticasone dose during the trial.
Results: Among 192 randomized participants (mean age, 9.8 years; 77 girls [40%]), 180 (93.8%) completed the trial. A total of 36 participants (37.5%) in the vitamin D3 group and 33 (34.4%) in the placebo group had 1 or more severe exacerbations. Compared with placebo, vitamin D3 supplementation did not significantly improve the time to a severe exacerbation: the mean time to exacerbation was 240 days in the vitamin D3 group vs 253 days in the placebo group (mean group difference, -13.1 days [95% CI, -42.6 to 16.4]; adjusted hazard ratio, 1.13 [95% CI, 0.69 to 1.85]; P = .63). Vitamin D3 supplementation, compared with placebo, likewise did not significantly improve the time to a viral-induced severe exacerbation, the proportion of participants whose dose of inhaled corticosteroid was reduced, or the cumulative fluticasone dose during the trial. Serious adverse events were similar in both groups (vitamin D3 group, n = 11; placebo group, n = 9).
Conclusions And Relevance: Among children with persistent asthma and low vitamin D levels, vitamin D3 supplementation, compared with placebo, did not significantly improve the time to a severe asthma exacerbation. The findings do not support the use of vitamin D3 supplementation to prevent severe asthma exacerbations in this group of patients.
Trial Registration: ClinicalTrials.gov Identifier: NCT02687815.
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http://dx.doi.org/10.1001/jama.2020.12384 | DOI Listing |
Front Immunol
December 2024
Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
Background: Autoimmune diseases pose significant health challenges worldwide and affect millions. In recent years, there has been growing interest in exploring preventive strategies through nutritional interventions using vitamins, antioxidants, and micronutrients to reduce the risk of developing autoimmune diseases. However, excessive supplementation has also been associated with toxicity.
View Article and Find Full Text PDFJ Clin Transl Endocrinol
December 2024
Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270 Rama 6 Road, Ratchathewi, Bangkok 10400, Thailand.
Introduction: In Thailand, the assessment of vitamin D status by measuring 25-hydroxyvitamin D[25(OH)D] levels in individuals at risk for osteoporosis is constrained by limited facilities and high costs. This study aimed to create a clinical model for predicting vitamin D deficiency in women with osteoporosis or risk factors for osteoporosis.
Materials And Methods: This was a cross-sectional study of 490 women.
Adv Biomed Res
October 2024
Department of Biostatistics and Epidemiology, School of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Background: Vitamin D leads to the activation of macrophages and limitation of intracellular growth of Mycobacterium tuberculosis. Vitamin D receptor (VDR) gene polymorphisms can facilitate the development of tuberculosis (TB). Therefore, the present study aimed to investigate the effect of vitamin D supplementation on response to treatment in patients with pulmonary TB for different VDR polymorphisms.
View Article and Find Full Text PDFFront Endocrinol (Lausanne)
December 2024
Department of Pediatrics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Central precocious puberty (CPP) is an endocrine disease in children, characterized by rapid genital development and secondary sexual characteristics before the age of eight in girls and nine in boys. The premature activation of the hypothalamic-pituitary-gonadal axis (HPGA) limits the height of patients in adulthood and is associated with a higher risk of breast cancer. How to prevent and improve the prognosis of CPP is an important problem.
View Article and Find Full Text PDFInt J Gen Med
December 2024
Department of Child Health, King Khalid University, Abha, 62529, Saudi Arabia.
Background: Evidence suggests a strong association between vitamin D status and asthma, with individuals exhibiting vitamin D deficiency demonstrating increased prevalence and severity of asthma symptoms. This study aimed to determine the prevalence of vitamin D deficiency among asthmatic children, assess the association between vitamin D status and asthma severity/control, and identify potential predictors of vitamin D deficiency in this population.
Patients And Methods: This comparative cross-sectional, hospital-based study was conducted at Abha Maternity and Children's Hospital, a tertiary care and teaching institution in southwestern Saudi Arabia, between January 2023 and May 2024.
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