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

NCT ID: NCT03988517

Last Updated: 2019-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2018-01-08

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.

Conditions

Hypothyroidism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

levothyroxine at Iftar

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

Group Type: ACTIVE_COMPARATOR

timing of receiving the drug

Intervention Type: OTHER

each group took levothyroxine in different timing

Levothyroxine at Suhour

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

Group Type: ACTIVE_COMPARATOR

timing of receiving the drug

Intervention Type: OTHER

each group took levothyroxine in different timing

Interventions

timing of receiving the drug

each group took levothyroxine in different timing

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamad Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Dr. ZEINAB DABBOUS

Consultant Endocrine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wajiha Abu Haliqa, MD

Role: PRINCIPAL_INVESTIGATOR

Hamad Medical Corporation

Locations

Hamad General Hospital

Doha, , Qatar

Countries

Qatar

Other Identifiers

ZDABBOUS

Identifier Type: -

Identifier Source: org_study_id