NCT03988517

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Hamad Medical Corporation · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypothyroidism

Interventions

Type	Name	Description
OTHER	timing of receiving the drug	each group took levothyroxine in different timing

Timeline

• Start date: 2017-02-01
• Primary completion: 2018-01-08
• Completion: 2018-01-08
• First posted: 2019-06-17
• Last updated: 2019-06-19

Locations

1 site across 1 country: Qatar