NCT06135948

Impact of Increasing Levothyroxine Dose in Ramadan for UAE Patients With Hypothyroidism

Impact of Increasing Levothyroxine Dose in Ramadan for UAE Patients With Hypothyroidism: a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Emirates Health Services (EHS) · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The study aims to compare the mean change in Thyroid Stimulating Hormone (TSH) levels among patients with hypothyroidism treated with an increased dose of L-thyroxine (treatment group) versus standard/regular dose of L-thyroxine (control group) during the month of Ramadan.

Detailed description

The present study is an open-label, two-arm parallel groups, randomized controlled clinical trial that included Emirati patients with hypothyroidism who attended the Family Promotion Centre, Endocrinology Clinic, regularly. Eligible participants (n = 103) were randomly allocated to the treatment group (patients who received an increased dose of L-thyroxine, 25 mcg, n = 50) and the control group (patients who received standard/regular dose of L-thyroxine, n = 46). Both groups attended 5 visits before, during, and after Ramadan. Several tests were conducted including thyroid function, lipid profile, HbA1c, and Vitamin D.

Conditions

• L-thyroxine

Interventions

Type	Name	Description
DRUG	Extra dose of L-thyroxine, 25 mcg during Ramadan	Extra dose of L-thyroxine, 25 mcg during the month of Ramadan

Timeline

• Start date: 2022-03-15
• Primary completion: 2022-06-15
• Completion: 2022-06-15
• First posted: 2023-11-18
• Last updated: 2023-11-18

Locations

1 site across 1 country: United Arab Emirates