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