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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Doha, Qatar, 3050
- Hamad General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
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)
|
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)
|
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
Time Frame: 1 month
|
To evaluate the change in TSH level before and after Ramadan in the two groups.
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1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wajiha Abu Haliqa, MD, Hamad Medical Corporation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZDABBOUS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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