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

Not Applicable

Completed

• Conditions: Hypothyroidism
• Interventions: Other: timing of receiving the drug

• Registration Number: NCT03988517
• Lead Sponsor: Hamad Medical Corporation

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2018-01-08
• Study Completion: 2018-01-08
• Status Verified: 2019-06
• Study First Submitted: 2019-06-11
• Study First Submitted QC: 2019-06-14
• Study First Posted: 2019-06-17
• Last Update Submitted: 2019-06-17
• Last Update Posted: 2019-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
levothyroxine at Iftar	timing of receiving the drug	Patients took levothyroxine 30 minutes before breaking the fast at sunset (iftar)
Levothyroxine at Suhour	timing of receiving the drug	Patients took levothyroxine 30 minutes before an early morning meal before sunrise (suhour)

Primary Outcome Measures

Name	Time	Method
Change in TSH level	1 month	To evaluate the change in TSH level before and after Ramadan in the two groups.

Secondary Outcome Measures

Name	Time	Method
convenience and compliance	1 month	To determine in each group if the timing of levothyroxine dose was convenient and check the compliance with instructions to take levothyroxine in the assigned time. Done through clinical interview

Trial Locations

Locations (1)

Hamad General Hospital; 🇶🇦 Doha, Qatar