Different Regimens in Treatment of Hypothyroidism During Fasting in RamadanNCT05918497
Comparison Between Variable Time Regimen of Dosing L-Thyroxine for Treatment Hypothyroid Fasting Ramadan
An observational study of Different Regimens in Treatment of Hypothyroidism During Fasting in Ramadan, run by Sohag University at 1 site in Egypt.
Trial summary
This is a study aiming to report the effect of a variable time regimen of L T4 during Ramadan, as an easier alternative, on adherence and thyroid status after Ramadan compared to standard daily dosing. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Different Regimens in Treatment of Hypothyroidism During Fasting in Ramadan
- How many people
- 89 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Apr 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: including Muslim hypothyroid patients willing to fast Ramadan during the year 2023 attending outpatient clinic, Sohag faculty of medicine, Sohag university, Egypt
Who may be able to join
- All included patients will be euthyroid, and stable on the same L T4 dose for at least 3 months before the start of Ramadan.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This is a study aiming to report the effect of a variable time regimen of L T4 during Ramadan, as an easier alternative, on adherence and thyroid status after Ramadan compared to standard daily dosing.
Read the detailed description
Patient and Method This a prospective study will be including Muslim hypothyroid patients willing to fast Ramadan during the year 2023 attending outpatient clinic, Sohag faculty of medicine, Sohag university, Egypt.
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.
- Keywords
- levothyroxin , hypothyroidism , fasting in Ramadan
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 a standard daily basis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison Between Variable Time Regimen of Dosing L-Thyroxine for Treatment Hypothyroid Fasting Ramadan
Measured: 2 months after ramadan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start25 Apr 2023
- Primary completion25 Dec 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Different Regimens in Treatment of Hypothyroidism During Fasting in RamadanStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Ahmed Mohamed, Sohag University
- Investigators
- Sara Kasem, lecturer, Study chair, sohag university .faculty of medicineAhmed Faysal, lecturer, Study chair, sohag university .faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918497
- Sponsor's protocol ID
- Soh-Med-23-04-08PD.
- Status last verified
- Apr 2024
- First submitted
- 15 Jun 2023
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Variable Time Regimen of Dosing L-Thyroxine for Treatment Hypothyroid Fasting Ramadan
- ClinicalTrials.gov ID
- NCT05918497
- Acronym / sponsor ID
- Soh-Med-23-04-08PD.
- Keywords
- levothyroxin , hypothyroidism , fasting in Ramadan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study aiming to report the effect of a variable time regimen of L T4 during Ramadan, as an easier alternative, on adherence and thyroid status after Ramadan compared to standard daily dosing.
Detailed description
Patient and Method This a prospective study will be including Muslim hypothyroid patients willing to fast Ramadan during the year 2023 attending outpatient clinic, Sohag faculty of medicine, Sohag university, Egypt.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 a standard daily basis. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- including Muslim hypothyroid patients willing to fast Ramadan during the year 2023 attending outpatient clinic, Sohag faculty of medicine, Sohag university, Egypt
Key inclusion criteria (1 listed)
- All included patients will be euthyroid, and stable on the same L T4 dose for at least 3 months before the start of Ramadan.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison Between Variable Time Regimen of Dosing L-Thyroxine for Treatment Hypothyroid Fasting Ramadan
Time frame: 2 months after ramadan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Kasem, lecturer study chair
sohag university .faculty of medicine
Ahmed Faysal, lecturer study chair
sohag university .faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Different Regimens in Treatment of Hypothyroidism During Fasting in Ramadan, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison Between Variable Time Regimen of Dosing L-Thyroxine for Treatment Hypothyroid Fasting Ramadan (time frame: 2 months after ramadan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.