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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypothyroidism

Intervention / Treatment
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* Other: timing of receiving the drug


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: patients were block randomized into two groups according to the time they are going to take the leovthyroxine tablet
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: levothyroxine at Iftar<br>Patients took levothyroxine 30 minutes before breaking the fast at sunset (iftar) | Other: timing of receiving the drug<br>* each group took levothyroxine in different timing<br>|
| Active Comparator: Levothyroxine at Suhour<br>Patients took levothyroxine 30 minutes before an early morning meal before sunrise (suhour) | Other: timing of receiving the drug<br>* each group took levothyroxine in different timing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TSH level | To evaluate the change in TSH level before and after Ramadan in the two groups. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| convenience and compliance | 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 | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fasting