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临床试验/CTRI/2025/06/089903
CTRI/2025/06/089903尚未招募不适用

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.”

Sujit Das1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月17日最近更新:

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

发起方
Sujit Das
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sujit Das

AIIMS Deoghar

研究点 (1)

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