Comparison Between Variable Time Regimen of Dosing L-Thyroxine for Treatment Hypothyroid Fasting Ramadan
NCT ID: NCT05918497
Last Updated: 2024-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
89 participants
OBSERVATIONAL
2023-04-25
2024-06-30
Brief Summary
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Detailed Description
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All included patients will be euthyroid, and stable on the same L T4 dose for at least 3 months before the start of Ramadan.
Exclusion criteria will be thyroid cancer patients requiring suppressive therapy, central hypothyroidism, pregnancy, coronary heart disease, arrythmia, chronic heart failure, liver cirrhosis, renal failure, acute medical, or surgical illness at the time of evaluation to avoid acute and chronic non thyroidal illness syndromes.
the patients will be divided into three groups. Group 1 patients who will switch to twice weekly dosing. Their weekly dose was divided equally into those doses, given at successive fixed days of the week. Group 2 patients who will switch to once weekly dosing. Group 3 patients who will continue to take L T4 on standard daily basis.
Patients from are free to follow one of four L T4 regimens during Ramadan, regimen 1: to take L T4 60 min before Iftar and beverages, regimen 2: to take L T4 3-4 h after Iftar, 60 min before Suhor meal, regimen 3: to take L T4 before the start of next fast 3 4 h after an early Suhor at midnight. If patients mixed between regimens 1 and 2, this was labeled regimen 4.
Adherence will assess by interviewing participants during post Ramadan visit. Nonadherence define as stopping food and beverages for less than 3 h before L T4 tablet(s) or stopping food and beverages for less than 45 min after L T4 tablet(s). Patients who skipped L T4 treatment for 2 or more days without making up for their missed doses will be excluded from the study.
Thyroid status will reassess in post Ramadan visit using TSH, provided that this visit comes within 6 weeks from the end of Ramadan.
Ethical aspect Informed written consent will be taken from all patients to include their data in the study. The research will be approved by medical ethics committee of Sohag University Faculty of Medicine Statistical analysis Data will be analyzed using STATA version 14.2 (Statistical Software: Release 14.2 College Station, TX: Stata Corp LP). Quantitative data will be represented as mean, standard deviation, median and range. normally distributed. Qualitative data will be presented as numbers and percentages. Chi square test will be used for comparison of percentages in different groups. P value will be considered significant if it was less than 0.05.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Group 1
.patients who will switch to twice weekly dosing. Their weekly dose was divided equally into those doses, given at successive fixed days of the week
No interventions assigned to this group
Group 2
patients who will switch to once-weekly dosing.
No interventions assigned to this group
Group 3
patients who will continue to take L T4 on a standard daily basis.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
20 Years
60 Years
ALL
No
Sponsors
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Sohag University
OTHER
Responsible Party
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Hany Ahmed Mohamed
lecturer of internal medicine
Principal Investigators
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Sara Kasem, lecturer
Role: STUDY_CHAIR
sohag university .faculty of medicine
Ahmed Faysal, lecturer
Role: STUDY_CHAIR
sohag university .faculty of medicine
Locations
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Sohag Faculty of Medicine
Sohag, , Egypt
Countries
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Other Identifiers
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Soh-Med-23-04-08PD.
Identifier Type: -
Identifier Source: org_study_id
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