HypothyroidismPhase 2NCT05733078
Effect of Vitamin C Supplementation in Patients With Primary Hypothyroidism
A Phase 2 study testing Vitamin C and Oral Rehydration Salt Formulations in people with Hypothyroidism and Primary Hypothyroidism, run by Dr Adnan Agha at 1 site in United Arab Emirates.
Trial summary
Thyroid disease affects almost a quarter of a billion individuals worldwide and more than 50% of them being not aware of this condition. The commonest thyroid disease is iodine deficiency related thyroid dysfunction with nearly 2 billion people around the globe at risk with insufficient iodine intake. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypothyroidism, Primary Hypothyroidism, Vitamin C Deficiency
- What is being tested?
- Vitamin C and Oral Rehydration Salt Formulations
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Nov 2023to Jun 2024
- Phase
- Phase 2
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18; both male or female
- Diagnosed to have Primary hypothyroidism > 6 months.
- Under follow up in Endocrine clinic in Tawam hospital during the 6 months
- No evidence of secondary hypothyroidism (no pituitary problems/surgery or thyroid surgery/ablation)
- TSH > 4 despite being on > 1.6 ug/kg/day of Levothyroxine for more than 8 weeks
Who cannot join
- Presence of coeliac disease
- Presence of selenium or iodine deficiency
- Gastric/intestinal resection surgery or confirmed malabsorption syndromes
- Known mental health issues affecting compliance
- Patient unable to consent.
- Overt biochemical hypothyroidism with TSH > 20 or T4 < 6
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Internal Medicine, College of Medicine and Health Sciences
Al Ain City, Abu Dhabi Emirate, 15551
Adnan Agha, +971-3-7673333 ext. 7677, adnanagha@uaeu.ac.ae
About this study
Official title: Effect of Vitamin C Supplementation in Patients With Primary Hypothyroidism Requiring High Levothyroxine Dosage; a Randomized Control Trial
Thyroid disease affects almost a quarter of a billion individuals worldwide and more than 50% of them being not aware of this condition. The commonest thyroid disease is iodine deficiency related thyroid dysfunction with nearly 2 billion people around the globe at risk with insufficient iodine intake. Autoimmune thyroid disorders are commonest cause of thyroid dysfunction in iodine sufficient parts of the world. Sub-optimally or untreated hypothyroidism can lead to cognitive decline, dyslipidemia, hypertension, infertility as well as cardiovascular and neuromuscular problems. The prevalence of hypothyroidism can vary in general population with up-to 5.3% people with overt hypothyroidism based on studies from the West, with estimated 10% of the population having subclinical hypothyroidism globally. In the gulf region however, there are no national studies that provide insight into exact prevalence of hypothyroidism, however some cross-sectional screening studies indicate frequency of hypothyroidism to be as high as 5-10%.
Levothyroxine is a synthetic hormone with structure similar to naturally occurring thyroxine, and it is used as replacement monotherapy of hypothyroidism. It is mainly absorbed via small intestine. The optimal daily levothyroxine dosage requirement is 1.6 microgram/kg body weight/day, which can normalize TSH in most patients, however many studies indicate that nearly half the patient on replacement therapy may not attain a normal TSH and require further doses, possibly due to interference or malabsorption. Multiple dose change and repeated diagnostic procedures in these patients can not only increased health costs but increased of ensuing complications secondary to sub-optimally controlled hypothyroidism. Instead of increasing levothyroxine doses and getting variable response, recent study have shown improvement in thyroid function by adding on vitamin C alongside levothyroxine dose, albeit only in a specific subset of patient having gastritis. The effect of Vitamin C on improving levothyroxine also been shown to be effective over a short period in a non-randomized, non-controlled setting. Our study aims to investigate whether addition of vitamin C to levothyroxine can improve the biochemical and clinical thyroid status in a randomized controlled setting.
Read the detailed description
Nearly 20-50% patients with hypothyroidism do not achieve normal TSH on levothyroxine replacement and two common reasons are interference in absorption and compliance. This study aims to evaluate the effects of oral vitamin C given alongside oral levothyroxine in compliant patient with clinical/biochemical hypothyroidism despite being on optimal daily dose of levothyroxine, in terms of biochemical improvement of thyroid function status. This may help patients requiring more than recommended daily dose (> 1.6 ug/kg per day of oral levothyroxine) to achieve euthyroid status without increasing total levothyroxine dose by just adding vitamin C (which authors feel may help with improving absorption of Levothyroxine).
OBJECTIVE:
To measure the biochemical and clinical responses in thyroid status with additional oral vitamin C in patients with features of hypothyroidism who are already on recommended daily dose of >1.6 ug/kg/day of oral levothyroxine.
METHODOLOGY:
STUDY DESIGN:
This is a prospective randomized controlled study in which all adult patients known to have primary hypothyroidism, attending Tawam Hospital Endocrine clinic for the last 6 months, and fulfilling the criteria below, will be selected. We will aim to include minimum 32 patients. The study power calculations for population of Al Ain estimated 650,000 with an estimated global prevalence of hypothyroidism being around 6% and expected 20-50% (taken as 33%) with suboptimal thyroid function, indicates need for minimum 31 patient with confidence interval of 95% and margin of error as 5%. The patients will be randomized to either control or intervention group (16 in each group).
- Conditions
- Hypothyroidism, Primary Hypothyroidism, Vitamin C Deficiency
- Being tested
- Vitamin C, Oral Rehydration Salt Formulations
- Medical subject headings
- Hypothyroidism, Ascorbic Acid Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
The patient in test group will be provided vitamin C effervescent tablets to use 1 gram daily with their usual dose of Levothyroxine for 12 weeks, with thyroid function tests assessed at 6 and 12 weeks. The patients who wish to continue at the end of 12 weeks will be provided another 12 weeks supply of vitamin C effervescent tablets to use 1 gram daily with their usual dose of Levothyroxine for with thyroid function tests and clinical score assessed at the end of week 24.
Oral Rehydration Salt FormulationsDrug
Also called Vitamin C
The patients in control group will have a oral rehydration effervescent tablet to take with their usual dose of Levothyroxine for 12 weeks, with thyroid function tests assessed at 6 and 12 weeks. The control group will then be provided vitamin C (intervention) effervescent tablets to use 1 gram daily with their usual dose of Levothyroxine for 12 weeks, with thyroid function tests assessed at 6 and 12 weeks to see if there is any difference on biochemical testing or clinical scores.
| Study group | Role | What they receive |
|---|---|---|
| Control / Crossover | Placebo comparator | The patients in control group will have a oral rehydration effervescent tablet to take with their usual dose of Levothyroxine for 12 weeks, with thyroid function tests assessed at 6 and 12 weeks.
Crossover: After first 12 weeks, the control group will then be provided vitamin C (intervention) effervescent tablets to use 1 gram daily with their usual dose of Levothyroxine for 12 weeks, with thyroid function tests assessed at 6 and 12 weeks to see if there is any difference on biochemical testing or clinical scores. Receives: Drug: Oral Rehydration Salt Formulations |
| Intervention | Experimental | The patient in test group will be provided vitamin C effervescent tablets to use 1 gram daily with their usual dose of Levothyroxine for 12 weeks, with thyroid function tests assessed at 6 and 12 weeks. The patients who wish to continue at the end of 12 weeks will be provided another 12 weeks supply of vitamin C effervescent tablets to use 1 gram daily with their usual dose of Levothyroxine for with thyroid function tests and clinical score assessed at the end of week 24. Receives: Drug: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Thyroid function (TSH)
The primary outcome will be assessing the change in TSH levels in mIU/ml before and after supplementation the same levothyroxine dose with and without intervention (1 gram of effervescent vitamin C).
Measured: 24 weeks
Change in Thyroid function (T4)
The primary outcome will be assessing the change in T4 levels in pmol/L before and after supplementation the same levothyroxine dose with and without intervention (1 gram of effervescent vitamin C).
Measured: 24 weeks
Change in Thyroid function (T3)
The primary outcome will be assessing the change in T3 levels in pmol/L before and after supplementation the same levothyroxine dose with and without intervention (1 gram of effervescent vitamin C).
Measured: 24 weeks
Secondary outcomes (1)
Change in clinical status
The clinical response will be assessed by evaluating for any change in Billewicz index scoring scale questionnaires before and after intervention. Billewicz index score ≥ +25 for overt hypothyroidism; score of -30 to +25 (above -30 and below +25) for subclinical hypothyroidism; and score ≤ -30 for excluding hypothyroidism)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Nov 2023
- Primary completionMar 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization of patients: The patient will be randomized into control(placebo) and test (Vit C tablet) groups using the randomization code. The patients in treatment group will be provided vitamin C effervescent tablets to use 1 gram daily with their usual dose of Levothyroxine for 12 weeks. In the control group the patients will be given oral rehydration effervescent tablet as placebo with their usual dose of Levothyroxine for 12 weeks. The patient in test group will be provided vitamin C effervescent tablets to use 1 gram daily with their usual dose of Levothyroxine for 12 weeks, with thyroid function tests assessed at 6 and 12 weeks. The patients who wish to continue at the end of 12 weeks will be provided another 12 weeks supply of vitamin C effervescent tablets to use 1 gram daily with their usual dose of Levothyroxine for with thyroid function tests and clinical score assessed at the end of week 24.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Adnan Agha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Adnan Agha, United Arab Emirates University
- Investigators
- Adnan Agha, Principal investigator, United Arab Emirates University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733078
- Sponsor's protocol ID
- UAEU_CMHS_IM_DOH_2023/56
- Status last verified
- Jan 2024
- First submitted
- 2 Feb 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Benoist B, McLean E, Andersson M, Rogers L. Iodine deficiency in 2007: global progress since 2003. Food Nutr Bull. 2008 Sep;29(3):195-202. doi: 10.1177/156482650802900305.
PubMed 18947032Jubiz W, Ramirez M. Effect of vitamin C on the absorption of levothyroxine in patients with hypothyroidism and gastritis. J Clin Endocrinol Metab. 2014 Jun;99(6):E1031-4. doi: 10.1210/jc.2013-4360. Epub 2014 Mar 6.
PubMed 24601693Virili C, Antonelli A, Santaguida MG, Benvenga S, Centanni M. Gastrointestinal Malabsorption of Thyroxine. Endocr Rev. 2019 Feb 1;40(1):118-136. doi: 10.1210/er.2018-00168.
PubMed 30476027Agha A, Afandi B, Yasin J, Sharma C, Alshaer MH, Alshamsi MAS, Yaaqeib DE, Alblooshi BKE, AlKaabi J. Vitamin C supplementation in patients with hypothyroidism requiring high-dose levothyroxine: a proof-of-concept pilot study. Front Endocrinol (Lausanne). 2025 Oct 23;16:1679835. doi: 10.3389/fendo.2025.1679835. eCollection 2025.
PubMed 41210509
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin C Supplementation in Patients With Primary Hypothyroidism Requiring High Levothyroxine Dosage; a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05733078
- Acronym / sponsor ID
- UAEU_CMHS_IM_DOH_2023/56
- Conditions
- Hypothyroidism, Primary Hypothyroidism, Vitamin C Deficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dr Adnan AghaUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 17 Feb 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.
Thyroid disease affects almost a quarter of a billion individuals worldwide and more than 50% of them being not aware of this condition. The commonest thyroid disease is iodine deficiency related thyroid dysfunction with nearly 2 billion people around the globe at risk with insufficient iodine intake. Autoimmune thyroid disorders are commonest cause of thyroid dysfunction in iodine sufficient parts of the world. Sub-optimally or untreated hypothyroidism can lead to cognitive decline, dyslipidemia, hypertension, infertility as well as cardiovascular and neuromuscular problems. The prevalence of hypothyroidism can vary in general population with up-to 5.3% people with overt hypothyroidism based on studies from the West, with estimated 10% of the population having subclinical hypothyroidism globally. In the gulf region however, there are no national studies that provide insight into exact prevalence of hypothyroidism, however some cross-sectional screening studies indicate frequency of hypothyroidism to be as high as 5-10%.
Levothyroxine is a synthetic hormone with structure similar to naturally occurring thyroxine, and it is used as replacement monotherapy of hypothyroidism. It is mainly absorbed via small intestine. The optimal daily levothyroxine dosage requirement is 1.6 microgram/kg body weight/day, which can normalize TSH in most patients, however many studies indicate that nearly half the patient on replacement therapy may not attain a normal TSH and require further doses, possibly due to interference or malabsorption. Multiple dose change and repeated diagnostic procedures in these patients can not only increased health costs but increased of ensuing complications secondary to sub-optimally controlled hypothyroidism. Instead of increasing levothyroxine doses and getting variable response, recent study have shown improvement in thyroid function by adding on vitamin C alongside levothyroxine dose, albeit only in a specific subset of patient having gastritis. The effect of Vitamin C on improving levothyroxine also been shown to be effective over a short period in a non-randomized, non-controlled setting. Our study aims to investigate whether addition of vitamin C to levothyroxine can improve the biochemical and clinical thyroid status in a randomized controlled setting.
Detailed description
Nearly 20-50% patients with hypothyroidism do not achieve normal TSH on levothyroxine replacement and two common reasons are interference in absorption and compliance. This study aims to evaluate the effects of oral vitamin C given alongside oral levothyroxine in compliant patient with clinical/biochemical hypothyroidism despite being on optimal daily dose of levothyroxine, in terms of biochemical improvement of thyroid function status. This may help patients requiring more than recommended daily dose (> 1.6 ug/kg per day of oral levothyroxine) to achieve euthyroid status without increasing total levothyroxine dose by just adding vitamin C (which authors feel may help with improving absorption of Levothyroxine).
OBJECTIVE:
To measure the biochemical and clinical responses in thyroid status with additional oral vitamin C in patients with features of hypothyroidism who are already on recommended daily dose of >1.6 ug/kg/day of oral levothyroxine.
METHODOLOGY:
STUDY DESIGN:
This is a prospective randomized controlled study in which all adult patients known to have primary hypothyroidism, attending Tawam Hospital Endocrine clinic for the last 6 months, and fulfilling the criteria below, will be selected. We will aim to include minimum 32 patients. The study power calculations for population of Al Ain estimated 650,000 with an estimated global prevalence of hypothyroidism being around 6% and expected 20-50% (taken as 33%) with suboptimal thyroid function, indicates need for minimum 31 patient with confidence interval of 95% and margin of error as 5%. The patients will be randomized to either control or intervention group (16 in each group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomization of patients: The patient will be randomized into control(placebo) and test (Vit C tablet) groups using the randomization code. The patients in treatment group will be provided vitamin C effervescent tablets to use 1 gram daily with their usual dose of Levothyroxine for 12 weeks. In the control group the patients will be given oral rehydration effervescent tablet as placebo with their usual dose of Levothyroxine for 12 weeks. The patient in test group will be provided vitamin C effervescent tablets to use 1 gram daily with their usual dose of Levothyroxine for 12 weeks, with thyroid function tests assessed at 6 and 12 weeks. The patients who wish to continue at the end of 12 weeks will be provided another 12 weeks supply of vitamin C effervescent tablets to use 1 gram daily with their usual dose of Levothyroxine for with thyroid function tests and clinical score assessed at the end of week 24.
| Arm | Type | Receives |
|---|---|---|
| Control / Crossover | Placebo comparator | Drug: Oral Rehydration Salt FormulationsThe patients in control group will have a oral rehydration effervescent tablet to take with their usual dose of Levothyroxine for 12 weeks, with thyroid function tests assessed at 6 and 12 weeks. Crossover: After first 12 weeks, the control group will then be provided vitamin C (intervention) effervescent tablets to use 1 gram daily with their usual dose of Levothyroxine for 12 weeks, with thyroid function tests assessed at 6 and 12 weeks to see if there is any difference on biochemical testing or clinical scores. |
| Intervention | Experimental | Drug: Vitamin CThe patient in test group will be provided vitamin C effervescent tablets to use 1 gram daily with their usual dose of Levothyroxine for 12 weeks, with thyroid function tests assessed at 6 and 12 weeks. The patients who wish to continue at the end of 12 weeks will be provided another 12 weeks supply of vitamin C effervescent tablets to use 1 gram daily with their usual dose of Levothyroxine for with thyroid function tests and clinical score assessed at the end of week 24. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18; both male or female
- Diagnosed to have Primary hypothyroidism > 6 months.
- Under follow up in Endocrine clinic in Tawam hospital during the 6 months
- No evidence of secondary hypothyroidism (no pituitary problems/surgery or thyroid surgery/ablation)
- TSH > 4 despite being on > 1.6 ug/kg/day of Levothyroxine for more than 8 weeks
Key exclusion criteria (6 listed)
- Presence of coeliac disease
- Presence of selenium or iodine deficiency
- Gastric/intestinal resection surgery or confirmed malabsorption syndromes
- Known mental health issues affecting compliance
- Patient unable to consent.
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 |
|---|---|---|
| Vitamin CThe patient in test group will be provided vitamin C effervescent tablets to use 1 gram daily with their usual dose of Levothyroxine for 12 weeks, with thyroid function tests assessed at 6 and 12 weeks. The patients who wish to continue at the end of 12 weeks will be provided another 12 weeks supply of vitamin C effervescent tablets to use 1 gram daily with their usual dose of Levothyroxine for with thyroid function tests and clinical score assessed at the end of week 24. | Drug | Intervention |
| Oral Rehydration Salt FormulationsAlso: Vitamin CThe patients in control group will have a oral rehydration effervescent tablet to take with their usual dose of Levothyroxine for 12 weeks, with thyroid function tests assessed at 6 and 12 weeks. The control group will then be provided vitamin C (intervention) effervescent tablets to use 1 gram daily with their usual dose of Levothyroxine for 12 weeks, with thyroid function tests assessed at 6 and 12 weeks to see if there is any difference on biochemical testing or clinical scores. | Drug | Control / Crossover |
Primary outcome
Change in Thyroid function (TSH)
Time frame: 24 weeks
The primary outcome will be assessing the change in TSH levels in mIU/ml before and after supplementation the same levothyroxine dose with and without intervention (1 gram of effervescent vitamin C).
Change in Thyroid function (T4)
Time frame: 24 weeks
The primary outcome will be assessing the change in T4 levels in pmol/L before and after supplementation the same levothyroxine dose with and without intervention (1 gram of effervescent vitamin C).
Change in Thyroid function (T3)
Time frame: 24 weeks
The primary outcome will be assessing the change in T3 levels in pmol/L before and after supplementation the same levothyroxine dose with and without intervention (1 gram of effervescent vitamin C).
1 secondary outcome
Change in clinical status
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Background: PubMed 18947032de Benoist B, McLean E, Andersson M, Rogers L. Iodine deficiency in 2007: global progress since 2003. Food Nutr Bull. 2008 Sep;29(3):195-202. doi: 10.1177/156482650802900305.
- Background: PubMed 24601693Jubiz W, Ramirez M. Effect of vitamin C on the absorption of levothyroxine in patients with hypothyroidism and gastritis. J Clin Endocrinol Metab. 2014 Jun;99(6):E1031-4. doi: 10.1210/jc.2013-4360. Epub 2014 Mar 6.
- Background: PubMed 30476027Virili C, Antonelli A, Santaguida MG, Benvenga S, Centanni M. Gastrointestinal Malabsorption of Thyroxine. Endocr Rev. 2019 Feb 1;40(1):118-136. doi: 10.1210/er.2018-00168.
- Derived from this study: PubMed 41210509Agha A, Afandi B, Yasin J, Sharma C, Alshaer MH, Alshamsi MAS, Yaaqeib DE, Alblooshi BKE, AlKaabi J. Vitamin C supplementation in patients with hypothyroidism requiring high-dose levothyroxine: a proof-of-concept pilot study. Front Endocrinol (Lausanne). 2025 Oct 23;16:1679835. doi: 10.3389/fendo.2025.1679835. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
Adnan Agha principal investigator
United Arab Emirates University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin C and Oral Rehydration Salt Formulations in people with Hypothyroidism and Primary Hypothyroidism, run by Dr Adnan Agha at 1 site in United Arab Emirates.
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 5 inclusion and 6 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 11 Jan 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 United Arab Emirates. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Adnan Agha, FRCP (+971562790723 ext. 7677, adnanagha@uaeu.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Thyroid function (TSH) (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05733078, which also lists 4 linked publications.
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 11 Jan 2024.