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临床试验/NCT01395589
NCT01395589已完成1 期

Rapid vs Maintenance Vitamin D Supplementation in Deficient Children With Asthma to Prevent Exacerbations

Hamad Medical Corporation1 个研究点 分布在 1 个国家目标入组 597 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
597
试验地点
1
主要终点
Acute asthma exacerbations avoidable events .

研究概览

简要总结

The role of vitamin D in respiratory health remains uncertain. Whether vitamin D reduces clinically important exacerbations of childhood asthma remains uncertain. We compared rapid to maintenance vitamin D repletion analyzed by baseline vitamin D level.

详细描述

Recently published Cochrane metaanalysis suggested that vitamin D reduces the risk of severe asthma exacerbations, but only 22 children contributed to that analysis from a study that found no difference in acute care visits or rescue steroid administration. Altogether, randomized trials performed in children show promise solely in meta-analyses that use varied clinical outcomes and analysis approaches.

Were vitamin D supplementation beneficial for children with asthma, it might prevent moderate to severe asthma exacerbations entirely in some children, reduce the overall frequency of exacerbations in a treated group, or both. To examine these possibilities, we designed a randomized explanatory study comparing rapid vs maintenance vitamin D supplementation for children with moderate-to-severe asthma and with low baseline vitamin D levels .

Children presenting to the ED with moderate-to-severe asthma exacerbations and vitamin D levels < 25 ng/mL underwent masked randomization, and then open dosing to either IM+oral (the latter daily) therapy or daily oral-only therapy, and were followed for 12 months.The primary outcome was patient-initiated unplanned visits for asthma exacerbations,examined two ways: cumulative proportions with an exacerbation, and average exacerbation frequency. As this was a nutrient study, we analyzed treatment groups by quartile of baseline vitamin D level, collecting repeat levels and clinical observations at 3, 6, 9,and 12 months after enrollment.

One hundred and sixteen patients in the IM+oral cohort vs 115 in the oral-only cohort had similar mean (SD) baseline levels: 15.1 (5.4) vs 15.8 (5.2) ng/mL (range, 3-25 ng/mL). There was no difference in the primary outcome over the entire 12-month observation period. However, rapid IM+oral supplementation significantly reduced unplanned visits for asthma exacerbations for children with baseline levels of 3 to 11 ng/mL during the initial 3 months: the relative exacerbation rate for the IM+oral cohort compared with the oral-only cohort at 3 months was 0.48 (95% CI, 0.28-0.89; P ¼ .008); average exacerbation frequency per child analysis, relative rate 0.36 (95% CI, 0.13-0.87; P ¼ .017).

So Rapid compared to maintenance vitamin D supplementation for children with the lowest levels resulted in short- but not long-term reduction in asthma exacerbations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
2 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children 2-14 years of age with moderate to severe asthma and proved to be Vitamin D deficient by serum level.
  • EXCLUSION CRITERIA:
  • Prematurity (Gestational age 34 weeks or less)
  • Patients on vitamin D therapy
  • Patients on seizure medication or diuretics
  • Patients on chronic steroid use for other reasons than asthma
  • Patient with chronic liver or kidney disease
  • Patients with inherited bone disease
  • Patients with hypo or hyper parathyroidism
  • Patients with history of chronic lung disease other than asthma

排除标准

  • 未提供

研究组 & 干预措施

Injectable + oral vitamin D

Active Comparator

Children with moderate-to-severe asthma exacerbations and vitamin D levels < 25 ng/mL.

干预措施: Vitamin D (Drug)

Oral-only Vitamin D

Active Comparator

Children with moderate-to-severe asthma exacerbations and vitamin D levels < 25 ng/mL.

干预措施: Vitamin D (Drug)

结局指标

主要结局

Acute asthma exacerbations avoidable events .

时间窗: 12 month

Rapid compared to maintenance oral supplementation with vitamin D significantly reduced unplanned visits for asthma exacerbations for children with baseline levels of 3 to 11 ng/mL during the initial 3 months of treatment but not thereafter.

次要结局

  • Daily symptom burden differ in slow versus rapid vitamin D deficiency correction in patients with moderate to severe asthma(12 month)

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Khalid Ibrahim

Consultant

Hamad Medical Corporation

研究点 (1)

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