HypothyroidismNCT05421468
Timing of Thyroxine Dose In Ramadan
A study testing L-Thyroxine time B (5-15 minutes Before dawn) in people with Hypothyroidism, run by King Abdullah International Medical Research Center at 2 sites in Saudi Arabia.
Trial summary
A Randomized trial comparing two different timing of taking thyroxine in patients with Hypothyroidism during fasting the month of Ramadan. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- L-Thyroxine time B (5-15 minutes Before dawn)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 14 Mar 2022to 30 Oct 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Saudi patient (males and female) above 18 years with Primary hypothyroidism on levothyroxine replacement who are willing to fast during Ramadan.
- Patients with controlled thyroid function for last 3 months on same dose of levothyroxine.
Who cannot join
- Pregnant or lactating women.
- Uncontrolled thyroid function test three months prior Ramadan.
- Thyroid cancer patients who require suppressed TSH.
- Central Hypothyroidism, patient with acute illness.
- Patients diagnosed with malabsorption i.e., Celiac Disease, Short bowel, Bariatric surgeries
- Use of certain Medications like systemic glucocorticoids, activated charcoal, sucralfate, aluminum hydroxide antacid, bile acid sequestrants, iron, calcium carbonate, PPI, rifampicin, and antiepileptic medications
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- Renal or hepatic disease:
- Creatinine clearance <0.6 ml/s or serum creatinine ≥200 μmol/l
- Alanine transferase ≥2.5 times the upper limit of normal
- Active liver disease including jaundice, chronic hepatitis, previous liver transplant
- Unwillingness to be randomized or to sign informed consent
- Known Psychiatric Disorders
- Known uncontrolled substance abuse or alcoholism
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites, 2 recruiting
- Recruiting
Reem Alamoudi
Jeddah, 21423
Reem Alamoudi, 0122266666, amoudir@ngha.med.sa
Samah Nawar, MD
- Recruiting
KingAbullahIMRC
Jeddah
Reem M Alamoudi, 966505641595, amoudir@ngha.med.sa, refal2001@yahoo.com
About this study
Official title: Timing of Thyroxine Dose In Ramadan; a Randomized Control Trial
A Randomized trial comparing two different timing of taking thyroxine in patients with Hypothyroidism during fasting the month of Ramadan.
Read the detailed description
To date there is debate regarding the best timing of L-thyroxine administration during Ramadan as sufficient evidence is lacking. This study aims to compare two-time points of levothyroxine intake during Ramadan focusing on change in TSH, satisfaction and compliance.
A prospective, randomized, open label, multicenter Study. The first group will be will be instructed to take their L-thyroxin dose as per current guidlines at breaking of fast time (sunset) with sip of water then wait 30-60 minutes to consume Iftar meal. The second group (pre-Fajer prayer), patients are going to be instructed to take L-thyroxin dose immediately before start of fast, i.e. Alfajer (dawn) regardless of Suhoor time. The values of Thyroid stimulating hormone (TSH) will be measured two weeks before Ramadan, and 2-4 weeks after Ramadan for comparison.
- Conditions
- Hypothyroidism
- Being tested
- L-Thyroxine time B (5-15 minutes Before dawn)
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-Thyroxine time B (5-15 minutes Before dawn)Other
Taking thyroxine at two different time points in relation to fasting and food intake; just before dawn and start of fast compared to the usual timing of 30-60minutes after the sunset breakfast meal.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Iftar (Breaking the fast) | Active comparator | To take thyroxine at breaking of fast with sip of water then wait 30-60 miuntes to eat iftar (breakfast). Receives: Other: L-Thyroxine time B (5-15 minutes Before dawn) |
| Pre-Fajr (Starting the fast) | Experimental | To take thyroxine immediately before start of fast at predawn time regardless of last meal time. Receives: Other: L-Thyroxine time B (5-15 minutes Before dawn) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyroid function
Change in TSH level
Measured: 6 - 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start14 Mar 2022
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
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
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421468
- Sponsor's protocol ID
- ICT22J-001-01
- Status last verified
- Jun 2022
- First submitted
- 27 May 2022
- Last updated
- 16 Jun 2022
- 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 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Thyroxine Dose In Ramadan; a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05421468
- Acronym / sponsor ID
- ICT22J-001-01
- Conditions
- Hypothyroidism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 16 Jun 2022 (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.
A Randomized trial comparing two different timing of taking thyroxine in patients with Hypothyroidism during fasting the month of Ramadan.
Detailed description
To date there is debate regarding the best timing of L-thyroxine administration during Ramadan as sufficient evidence is lacking. This study aims to compare two-time points of levothyroxine intake during Ramadan focusing on change in TSH, satisfaction and compliance.
A prospective, randomized, open label, multicenter Study. The first group will be will be instructed to take their L-thyroxin dose as per current guidlines at breaking of fast time (sunset) with sip of water then wait 30-60 minutes to consume Iftar meal. The second group (pre-Fajer prayer), patients are going to be instructed to take L-thyroxin dose immediately before start of fast, i.e. Alfajer (dawn) regardless of Suhoor time. The values of Thyroid stimulating hormone (TSH) will be measured two weeks before Ramadan, and 2-4 weeks after Ramadan for comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Iftar (Breaking the fast) | Active comparator | Other: L-Thyroxine time B (5-15 minutes Before dawn)To take thyroxine at breaking of fast with sip of water then wait 30-60 miuntes to eat iftar (breakfast). |
| Pre-Fajr (Starting the fast) | Experimental | Other: L-Thyroxine time B (5-15 minutes Before dawn)To take thyroxine immediately before start of fast at predawn time regardless of last meal time. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Saudi patient (males and female) above 18 years with Primary hypothyroidism on levothyroxine replacement who are willing to fast during Ramadan.
- Patients with controlled thyroid function for last 3 months on same dose of levothyroxine.
Key exclusion criteria (13 listed)
- Pregnant or lactating women.
- Uncontrolled thyroid function test three months prior Ramadan.
- Thyroid cancer patients who require suppressed TSH.
- Central Hypothyroidism, patient with acute illness.
- Patients diagnosed with malabsorption i.e., Celiac Disease, Short bowel, Bariatric surgeries
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 |
|---|---|---|
| L-Thyroxine time B (5-15 minutes Before dawn)Taking thyroxine at two different time points in relation to fasting and food intake; just before dawn and start of fast compared to the usual timing of 30-60minutes after the sunset breakfast meal. | Other | Pre-Fajr (Starting the fast), Pre-Iftar (Breaking the fast) |
Primary outcome
Thyroid function
Time frame: 6 - 8 weeks
Change in TSH level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-Thyroxine time B (5-15 minutes Before dawn) in people with Hypothyroidism, run by King Abdullah International Medical Research Center at 2 sites in Saudi Arabia.
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 2 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyroid function (time frame: 6 - 8 weeks). 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 16 Jun 2022.