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临床试验/CTRI/2018/07/014777
CTRI/2018/07/014777已完成不适用

Vitamin -D Supplementation as an Adjunct to Standard Treatment of Asthma in Children: A Randomized Control Trial

AIIMS Jodhpur1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年12月7日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
AIIMS Jodhpur
入组人数
70
试验地点
1
主要终点
1.Primary outcome measure will be ACT score (which is a validated score and contained 5 items with minimum score of 5 to maximum score of 25) at 3 months

研究概览

简要总结

Asthma affects up to 15 % children and over a period of time there is increase in incidence.Evidence suggests that Vitamin-D deficiency is associated with increased airway hyper responsiveness, lower pulmonary functions, worse asthma control and possibly steroid resistance. Vitamin-D in lung epithelium inhibit synthesis and release of certain cytokines and decreases lung inflammation , it also have role in innate and adaptive immunity, thus Vitamin-d can help in improvement of asthma control. There are many studies till now with different doses of vitamin-D trial in asthma. Some had positive and some had no results .There are very few studies in India so far and studies done so far only shown to improve respiratory score & acute exacerbation. Pulmonary function indices  are not well studied till date .In our study we have chosen adequate dose of vitamin-D and pulmonary function parameters like FEV1, fraction excretion of  Nitirc oxide will be studied and compared to placebo. so our study will add on the effect of vitamin -D on these pulmonary function inidices.  Vitamin-D baseline level at enrollment and At the end of 3 months  after supplementation  will be compared along with other parameters. As our study include serum Vitamin-D levels and PFTs , it will be add on to existing knowledge and may cover-up the scope of research which is still need to be evaluated for VItamin-D and Asthma control.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
6.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Children 6 to 18 years of age, newly diagnosed case of asthma by Pediatrician.
  • (Clinical and/or PFT).
  • OR follow-up case of asthma in chest clinic at AIIMS
  • Those willing to take medication for 3 months and regular follow-up.

排除标准

  • Patients with history of prematurity, bronchopulmonary dysplasia, coexisting primary parenchymal pulmonary disease (e.g. cystic fibrosis) or coexisting congenital/acquired heart diseases, and patients of epilepsy on anticonvulsants.
  • Known case of Vitamin –D deficiency.
  • History of intake of Vitamin-D and calcium in past 1 month.
  • Known case of any disease involving Vitamin-D & calcium metabolism.
  • Consent not given.
  • Those with hypercalcemia or allergy to Vitamin- D.

结局指标

主要结局

1.Primary outcome measure will be ACT score (which is a validated score and contained 5 items with minimum score of 5 to maximum score of 25) at 3 months

时间窗: 1.Enrollment will be done in 1st 3 months | 2.Interventions will start at the time of enrollment. | 3.Participants will be asked to visit clinic after every 15 days for follow-up.

次要结局

  • Secondary outcome measure will be FEV1, fraction excretion of nitric oxide, number of asthma exacerbation, serum 25-OH vitamin D3 at 3 months and adverse outcome, no. of emergency visits, use of systemic steroid.(1.Enrollment will be done in 1st 3 months)

研究者

发起方
AIIMS Jodhpur
申办方类型
Government medical college

研究点 (1)

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