Trial to Evaluate the Efficacy of a Zinc, Selenium, and L-Tyrosine Supplement in the Prevention of Thyrotoxicosis in Subjects With r25191G/A SEPP1 Polymorphism

Launched by S.LAB (SOLOWAYS) · Feb 9, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at whether a supplement containing zinc, selenium, and L-tyrosine can help prevent a condition called thyrotoxicosis in certain adults. Thyrotoxicosis happens when there is too much thyroid hormone in the body, which can lead to various health issues. The study will include adults aged 18 to 85 who have a specific genetic marker (known as the r25191G/A SEPP1 polymorphism) and elevated levels of thyroid antibodies. However, people with existing thyroid disease, pregnant or breastfeeding women, and those allergic to the supplement ingredients cannot participate.

Participants in this trial will take either the supplement or a placebo (a non-active pill) for six months. Throughout this period, researchers will monitor changes in thyroid levels and antibodies to see if the supplement can reduce the risk of developing thyrotoxicosis. The trial aims to enroll around 150 people in each group, and it will be conducted in a way that neither the participants nor the researchers know who is receiving the actual supplement or the placebo, which helps ensure the results are reliable.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Confirmed presence of one or more specified gene polymorphism r25191G/A SEPP1
• • TPOAb levels \> 300 IU/mL
• Exclusion Criteria:
• • Age \< 18 years and \>85
• • Pregnant or breastfeeding woman
• • Subjects with allergy to any of the supplementation component patients with any established diagnosis of thyroid disease