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

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.

Study Overview

• Status: Completed
• Conditions: Hypothyroidism
• Intervention / Treatment: Other: timing of receiving the drug

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 Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Qatar
  • Doha, Qatar, 3050
    • Hamad General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hamad Medical Corporation
• Investigators: Principal Investigator: Wajiha Abu Haliqa, MD, Hamad Medical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): January 8, 2018
• Study Completion (Actual): January 8, 2018

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): June 19, 2019
• Last Update Submitted That Met QC Criteria: June 17, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: fasting
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hypothyroidism
• Other Study ID Numbers: ZDABBOUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan to share individual participant data, but can provide them for researchers who ask for it

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No