Vitamin C supplementation for patients with primary hypothyroidism
Effect of Vitamin C Supplementation in Patients With Primary Hypothyroidism Requiring High Levothyroxine Dosage; a Randomized Control Trial
This study is testing if taking vitamin C can help people with primary hypothyroidism better absorb their thyroid medication and improve their hormone levels.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | United Arab Emirates University Academic / other |
| Locations | 1 site (Al Ain, Abu Dhabi) |
| Trial ID | NCT05733078 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of oral vitamin C supplementation in patients diagnosed with primary hypothyroidism who are already receiving an optimal dose of levothyroxine but still exhibit suboptimal thyroid function. The study aims to determine if vitamin C can enhance the absorption of levothyroxine, potentially allowing patients to achieve normal thyroid hormone levels without increasing their medication dosage. A total of at least 32 adult participants will be recruited from the Tawam Hospital Endocrine clinic, and their biochemical responses will be measured over the course of the trial. The study is designed as a prospective randomized controlled trial to ensure robust results.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with diagnosed primary hypothyroidism who have been on levothyroxine for more than 8 weeks but still have elevated TSH levels.
Not a fit: Patients with coeliac disease, malabsorption syndromes, or those with overt biochemical hypothyroidism may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help patients achieve better thyroid function without the need for higher doses of levothyroxine.
How similar studies have performed: While the use of vitamin C in this context is novel, other studies have explored vitamin supplementation in thyroid disorders, but results have been mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Al Ain, Abu Dhabi
- Internal Medicine, College of Medicine and Health Sciences — Al Ain, Abu Dhabi, United Arab Emirates (Recruiting)
Study contacts
- Principal investigator: Adnan Agha — United Arab Emirates University
- Study coordinator: Adnan Agha, FRCP
- Email: adnanagha@uaeu.ac.ae
- Phone: +971562790723
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.