Clinical trial NCT03988517: Comparing Two-time Points of Thyroid Hormone Replacement During the Holy Month of Ramadan
Official title: A Prospective Study Comparing Two-time Points of Thyroid Hormone Replacement During the Holy Month of Ramadan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothyroidism
Keywords: fasting
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2019-06-17
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients were block randomized into two groups according to the time they are going to take the leovthyroxine tablet
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in TSH level
timeFrame: 1 month
Secondary outcomes:
measure: convenience and compliance
timeFrame: 1 month
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad General Hospital
Study officials:
affiliation: Hamad Medical Corporation
name: Wajiha Abu Haliqa, MD
role: PRINCIPAL_INVESTIGATOR
References: