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临床试验/NCT03988517
NCT03988517已完成不适用

A Prospective Study Comparing Two-time Points of Thyroid Hormone Replacement During the Holy Month of Ramadan

Hamad Medical Corporation2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2017年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
2
主要终点
Change in TSH level

研究概览

简要总结

Muslims all over the world fast during the month of Ramadan from dawn until dusk. There is little data regarding the best timing of levothyroxine intake during the month of Ramadan where taking it on an empty stomach represents a challenge to most patients.This study aims to compare two-time points of levothyroxine intake during Ramadan in terms of change in thyroid stimulating hormone (TSH), compliance and convenience.

详细描述

Hypothyroidism requires regular replacement with levothyroxine to achieve euthyroidism (thyroid hormone status within the normal range). Usually, levothyroxine is taken orally in the morning on a daily basis. In clinical practice, the investigators have observed that this levothyroxine replacement is sub-optimal resulting in higher levels of thyroid stimulating hormone. Based on this observation, the investigators conducted this study to examine whether timing of oral intake of levothyroxine during the holy month of Ramadan will affect achievement of euthyroidism. They recruited 96 hypothyroid patients taking levothyroxine, attending Hamad endocrine outpatient clinics, who were fasting during Ramadan( May-June 2017)and for whom there is no clinical contraindication to fasting. Patients were randomly assigned to two time points for taking levothyroxine:

A. 30 minutes before the Iftar meal B. 30 minutes before Suhour The primary outcome was the change in thyroid stimulating hormone (TSH) before and after Ramadan. The null hypothesis is that there is no difference in TSH between the two groups.

The findings from the study will help in the clinical care of patients with hypothyroidism in Ramadan. Hypothyroidism is common worldwide and many Muslims will require the appropriate advice regarding management of hypothyroidism in Ramadan.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Primary hypothyroidism who had stable TSH over the last 6 months prior to the study period
  • Age between 18-70 years old
  • Patients who planned to fast during Ramadan.

排除标准

  • Patients with any end organ damage
  • Pregnant ladies
  • Patients with thyroid cancer
  • Patients not adhering to medications
  • Patients who had a clinical contraindication to observe fasting.

研究组 & 干预措施

levothyroxine at Iftar

Active Comparator

Patients took levothyroxine 30 minutes before breaking the fast at sunset (iftar)

干预措施: timing of receiving the drug (Other)

Levothyroxine at Suhour

Active Comparator

Patients took levothyroxine 30 minutes before an early morning meal before sunrise (suhour)

干预措施: timing of receiving the drug (Other)

结局指标

主要结局

Change in TSH level

时间窗: 1 month

To evaluate the change in TSH level before and after Ramadan in the two groups.

次要结局

  • convenience and compliance(1 month)

研究者

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

Dr. ZEINAB DABBOUS

Consultant Endocrine

Hamad Medical Corporation

研究点 (2)

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