Comparing Two-time Points of Thyroid Hormone Replacement During the Holy Month of Ramadan
Primary Purpose
Hypothyroidism
Status
Completed
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
timing of receiving the drug
Sponsored by
About this trial
This is an interventional treatment trial for Hypothyroidism focused on measuring fasting
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.
Sites / Locations
- Hamad General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
levothyroxine at Iftar
Levothyroxine at Suhour
Arm Description
Patients took levothyroxine 30 minutes before breaking the fast at sunset (iftar)
Patients took levothyroxine 30 minutes before an early morning meal before sunrise (suhour)
Outcomes
Primary Outcome Measures
Change in TSH level
To evaluate the change in TSH level before and after Ramadan in the two groups.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03988517
Brief Title
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
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
January 8, 2018 (Actual)
Study Completion Date
January 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamad Medical Corporation
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism
Keywords
fasting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
patients were block randomized into two groups according to the time they are going to take the leovthyroxine tablet
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
levothyroxine at Iftar
Arm Type
Active Comparator
Arm Description
Patients took levothyroxine 30 minutes before breaking the fast at sunset (iftar)
Arm Title
Levothyroxine at Suhour
Arm Type
Active Comparator
Arm Description
Patients took levothyroxine 30 minutes before an early morning meal before sunrise (suhour)
Intervention Type
Other
Intervention Name(s)
timing of receiving the drug
Intervention Description
each group took levothyroxine in different timing
Primary Outcome Measure Information:
Title
Change in TSH level
Description
To evaluate the change in TSH level before and after Ramadan in the two groups.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
convenience and compliance
Description
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
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wajiha Abu Haliqa, MD
Organizational Affiliation
Hamad Medical Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamad General Hospital
City
Doha
ZIP/Postal Code
3050
Country
Qatar
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share individual participant data, but can provide them for researchers who ask for it
Learn more about this trial
Comparing Two-time Points of Thyroid Hormone Replacement During the Holy Month of Ramadan
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