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

Hypothyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03988517
• Other study ID #: ZDABBOUS
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: January 8, 2018

Study information

• Verified date: June 2019
• Source: Hamad Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: January 8, 2018
• Est. primary completion date: January 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypothyroidism

Intervention

Other:
• timing of receiving the drug
each group took levothyroxine in different timing

Locations

Country	Name	City	State
Qatar	Hamad General Hospital	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in TSH level	To evaluate the change in TSH level before and after Ramadan in the two groups.	1 month
Secondary	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