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Completed

NCT Number: NCT03988517

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamad General Hospital

Doha, 3050, Qatar

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

timing of receiving the drug

Other

each group took levothyroxine in different timing

Primary outcomes

  1. Change in TSH level

    Time frame: 1 month

    To evaluate the change in TSH level before and after Ramadan in the two groups.

Secondary outcomes

  1. convenience and compliance

    Time frame: 1 month

    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

Sponsors and collaborators

Lead sponsor

Hamad Medical Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 17, 2019
Registry last updated
Jun 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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