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临床试验/CTRI/2017/10/010274
CTRI/2017/10/010274尚未招募不适用

Randomised Trial of Two Different Doses of Vitamin D Supplementation And Risk of Acute Respiratory Infection in Childrens in Rural Kolar, Karnataka.

Sri Devaraj Urs Academy of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2018年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
170
试验地点
1
主要终点
Number of Parent reported and Class teacher detected acute respiratory tract infections

研究概览

简要总结

Vitamin D is known to be of physiological importance outside of bone health and calcium homeostasis, and there is mounting evidence that it plays a beneficial role in the prevention and/or treatment of a wide range of diseases.  Vitamin D appears capable of inhibiting pulmonary inflammatory responses while enhancing innate defence mechanisms against respiratory pathogens. Epidemiological studies have shown that low serum 25-hydroxyvitamin D levels are associated with a higher risk of upper and lower respiratory infections in children. This knowledge is particularly relevant and timely, because infants and children appear more susceptible to viral rather than bacterial infections in the face of vitamin D deficiency. The connection between vitamin D, infections and immune function in the paediatric population indicates a possible role for vitamin D supplementation in potential interventions and adjuvant therapies.  The ideal amount of vitamin D intake needed to prevent the adverse health conditions associated with vitamin D insufficiency/deficiency remains unclear. Disagreements on cut-off values for vitamin D sufficiency in the pediatric population likewise complicate interpretation of the recommendations. Furthermore, recommendations for increased sunlight exposure to promote adequate cutaneous vitamin D3 synthesis will need to be balanced with concerns for the risks associated with the increased time spent in the sun exposed to UV radiation. Based on currently available research, however, support for supplementation greater than what prevents the most adverse outcomes (i.e.  Severe rickets) is strongly advocated. Population-based studies showing an association between circulating vitamin D levels and lung function provide strong justification for randomized controlled clinical trials of vitamin D supplementation in patients with respiratory diseases to assess both efficacy and optimal dosage.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

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

入选标准

  • •Healthy children by parental report.
  • •Age group of completed 3 years – 6th year running.
  • •Present to RL Jallappaschool in Kolar.
  • •Parents provide informed consent to participate.

排除标准

  • •Children with chronic illness (except for asthma) on parental report which is known to interfere with vitamin D metabolism and increase the risk of respiratory infection.
  • •Child having clinical rickets.
  • •Child already on vitamin supplementation.

结局指标

主要结局

Number of Parent reported and Class teacher detected acute respiratory tract infections

时间窗: upto 6 months

次要结局

  • Serum vitamin D levels.(Serum vitamin D levels at the time of Recuriment and at the end of each 3 Months of Vitamin D3 supplimentation.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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