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临床试验/CTRI/2018/04/013290
CTRI/2018/04/013290已完成不适用

Study of Effect of Vitamin D supplementation in Human Immunodeficiency Virus infected children

MOTI LAL NEHRU MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2016年12月15日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
IMMUNITY STATUS wuth CD4 count

研究概览

简要总结

This is a Non - Randomized active controlled trial to study the effect of supplementation of Vitamin D in HIV ( human immunodeficiency virus)  infected children on Highly Active Anti-Retroviral Treatment. Vitamin D levels were done in 51 HIV patients at enrolment .Patients ere divided in 4 groups by US endocrine Society Classification for Vitamin D levels...GROUP1-  HIV patients with vitamin D deficiency,  GROUP 2- HIV patients with insufficient Vitamin D levels, GROUP 3 - HIV  infected patients with vitamin D sufficient levels , GROUP 4- HIV infected patients with vitamin D toxicity. GROUP 1 & 2 Patients  were supplemented with Vitamin D   2,40,000 IU oral cholecalciferol sachets on day 1 followed by vitamin D3 drops 0.5ml (400 IU)  daily for 12 weeks (1ml = 800 IU) and vitamin D levels were repeated after 4 months. GROUP 3 & 4 placebo ( tab folic acid was given for 12 weeks. Primary Outcomes will be CD4  counts of both groups 1 and 2 will be compared .Secondary outcomes will be 1) Incidence of opportunistic infections in both group 1 and 2.... 2) comparison of CD4 count after vitamin D supplementation in Vitamin D deficient HIV infected children. At final evaluation,the above trial concluded that , CD4 count increased in Group 1,2 and 3 , there was no significant difference in mean CD4 count at all periods among the 3 groups. Similarly, opportunistic infections decrease in group 1,2 and 3 but the mean number of opportunistic infections between the groups at all periods did not differ significantly.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

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

入选标准

  • All HIV infected children with parents with 1) Age 18 months-18 years 2) On Highly Active Anti Retroviral Therapy.

排除标准

  • HIV infected children patients 1) Receiving any form of Vitamin D or Calcium supplementation 2) Having pre-existing tuberculosis or any other opportunistic infection.

结局指标

主要结局

IMMUNITY STATUS wuth CD4 count

时间窗: 4 months

次要结局

  • OPPORTUNISTIC INFECTIONS(4 months)

研究者

申办方类型
Government medical college

研究点 (1)

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