HypothyroidismNCT03988517
Comparing Two-time Points of Thyroid Hormone Replacement During the Holy Month of Ramadan
A study testing timing of receiving the drug in people with Hypothyroidism, run by Hamad Medical Corporation at 1 site in Qatar.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- timing of receiving the drug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteQatar
- Study dates
- 1 Feb 2017to 8 Jan 2018
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study Comparing Two-time Points of Thyroid Hormone Replacement During the Holy Month of Ramadan
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.
Read the 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:
- 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.
- Conditions
- Hypothyroidism
- Being tested
- timing of receiving the drug
- Keywords
- fasting
- Medical subject headings
- Hypothyroidism, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
timing of receiving the drugOther
each group took levothyroxine in different timing
| Study group | Role | What they receive |
|---|---|---|
| levothyroxine at Iftar | Active comparator | Patients took levothyroxine 30 minutes before breaking the fast at sunset (iftar) Receives: Other: timing of receiving the drug |
| Levothyroxine at Suhour | Active comparator | Patients took levothyroxine 30 minutes before an early morning meal before sunrise (suhour) Receives: Other: timing of receiving the drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TSH level
To evaluate the change in TSH level before and after Ramadan in the two groups.
Measured: 1 month
Secondary outcomes (1)
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start1 Feb 2017
- Primary completion8 Jan 2018
- Study completion8 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. ZEINAB DABBOUS, Hamad Medical Corporation
- Investigators
- Wajiha Abu Haliqa, MD, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988517
- Sponsor's protocol ID
- ZDABBOUS
- Status last verified
- Jun 2019
- First submitted
- 11 Jun 2019
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data, but can provide them for researchers who ask for it
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Comparing Two-time Points of Thyroid Hormone Replacement During the Holy Month of Ramadan
- ClinicalTrials.gov ID
- NCT03988517
- Acronym / sponsor ID
- ZDABBOUS
- Conditions
- Hypothyroidism
- Keywords
- fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 8 Jan 2018 (actual)
- First posted
- 17 Jun 2019 (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.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients were block randomized into two groups according to the time they are going to take the leovthyroxine tablet
| Arm | Type | Receives |
|---|---|---|
| levothyroxine at Iftar | Active comparator | Other: timing of receiving the drugPatients took levothyroxine 30 minutes before breaking the fast at sunset (iftar) |
| Levothyroxine at Suhour | Active comparator | Other: timing of receiving the drugPatients took levothyroxine 30 minutes before an early morning meal before sunrise (suhour) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| timing of receiving the drugeach group took levothyroxine in different timing | Other | Levothyroxine at Suhour, levothyroxine at Iftar |
Primary outcome
Change in TSH level
Time frame: 1 month
To evaluate the change in TSH level before and after Ramadan in the two groups.
1 secondary outcome
convenience and compliance
Time frame: 1 month
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 19 Jun 2019.
- Individual participant dataSharing planned: No. No plan to share individual participant data, but can provide them for researchers who ask for it
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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.
Wajiha Abu Haliqa, MD principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing timing of receiving the drug in people with Hypothyroidism, run by Hamad Medical Corporation at 1 site in Qatar.
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 3 inclusion and 5 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 19 Jun 2019. 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 Qatar. 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?
Change in TSH level (time frame: 1 month). 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 19 Jun 2019; AzTrials last refreshed its copy on 29 Oct 2026.