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临床试验/NCT05918497
NCT05918497已完成不适用

Comparison Between Variable Time Regimen of Dosing L-Thyroxine for Treatment Hypothyroid Fasting Ramadan

Sohag University1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2023年4月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
89
试验地点
1
主要终点
Comparison Between Variable Time Regimen of Dosing L-Thyroxine for Treatment Hypothyroid Fasting Ramadan

研究概览

简要总结

This is a study aiming to report the effect of a variable time regimen of L T4 during Ramadan, as an easier alternative, on adherence and thyroid status after Ramadan compared to standard daily dosing.

详细描述

Patient and Method This a prospective study will be including Muslim hypothyroid patients willing to fast Ramadan during the year 2023 attending outpatient clinic, Sohag faculty of medicine, Sohag university, Egypt.

All included patients will be euthyroid, and stable on the same L T4 dose for at least 3 months before the start of Ramadan.

Exclusion criteria will be thyroid cancer patients requiring suppressive therapy, central hypothyroidism, pregnancy, coronary heart disease, arrythmia, chronic heart failure, liver cirrhosis, renal failure, acute medical, or surgical illness at the time of evaluation to avoid acute and chronic non thyroidal illness syndromes.

the patients will be divided into three groups. Group 1 patients who will switch to twice weekly dosing. Their weekly dose was divided equally into those doses, given at successive fixed days of the week. Group 2 patients who will switch to once weekly dosing. Group 3 patients who will continue to take L T4 on standard daily basis.

Patients from are free to follow one of four L T4 regimens during Ramadan, regimen 1: to take L T4 60 min before Iftar and beverages, regimen 2: to take L T4 3-4 h after Iftar, 60 min before Suhor meal, regimen 3: to take L T4 before the start of next fast 3 4 h after an early Suhor at midnight. If patients mixed between regimens 1 and 2, this was labeled regimen 4.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All included patients will be euthyroid, and stable on the same L T4 dose for at least 3 months before the start of Ramadan.

排除标准

  • Exclusion criteria will be thyroid cancer patients requiring suppressive therapy, central hypothyroidism, pregnancy, coronary heart disease, arrythmia, chronic heart failure, liver cirrhosis, renal failure, acute medical, or surgical illness at the time of evaluation to avoid acute and chronic non thyroidal illness syndromes.

结局指标

主要结局

Comparison Between Variable Time Regimen of Dosing L-Thyroxine for Treatment Hypothyroid Fasting Ramadan

时间窗: 2 months after ramadan

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hany Ahmed Mohamed

lecturer of internal medicine

Sohag University

研究点 (1)

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