Effects of multiple cycle of vitamin-A[ 2 lakhs IU] along with oral zinc [50mg] supplementation on adult Bitots spots disappearance - A comparative study visiting Tertiary Care Hospital, AIIMS Deoghar.”
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The aim of the study is to see the total disappearance of Bitot’s spot with multiple cycle of vitamin-A [2lakhs IU] supplementation with no recurrence
研究概览
简要总结
This comparative interventional study will beconducted at the tertiary care center, AIIMS Deoghar, to evaluate the effects of multiple cycles of high-dose vitamin A and oral zinc supplementation on the disappearance of Bitot’s spots in adults. Patients presenting with clinically diagnosed Bitot’s spots will be recruited after obtaining informed consent. Eligible participants will be randomly assigned to two treatment arms. The control group received the conventional therapy comprising vitamin A supplementation at a dose of 2 lakh IU on day 1, day 3, and day 15, along with topical lubricating eye drops. The intervention group received repeated cycles of the same dose of vitamin A (2 lakh IU, on day 1, day 3, and day 15) every three weeks, for a maximum of six cycles, in addition to daily oral zinc supplementation (50 mg twice daily for 3 monts) and lubricating drops. Clinical assessment for Bitot’s spot resolution and any adverse effects will be performed at each follow-up visit. The primary outcome was the rate of disappearance of Bitot’s spots, and secondary outcomes included time to resolution and recurrence rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •All adult patients presented with Bitot’s spot will be included in the study.
排除标准
- •Patient with malnutrition, liver disease, cardiac disease, gastrointestinal disease and chronic alcoholic will be excluded from the study.
结局指标
主要结局
The aim of the study is to see the total disappearance of Bitot’s spot with multiple cycle of vitamin-A [2lakhs IU] supplementation with no recurrence
时间窗: Baeline, 2 years
次要结局
未报告次要终点
研究者
Sujit Das
AIIMS Deoghar
