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

Phase 4

Completed

• Conditions: L-thyroxine
• Interventions: Drug: Extra dose of L-thyroxine, 25 mcg during Ramadan

• Registration Number: NCT06135948
• Lead Sponsor: Emirates Health Services (EHS)

Brief 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.

Study Timeline

• Study Start: 2022-03-15
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-15
• Status Verified: 2023-11
• Study First Submitted: 2023-11-12
• Study First Submitted QC: 2023-11-12
• Last Update Submitted: 2023-11-16
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients with any end organ damage
2. Pregnant or Breast-feeding women
3. Thyroid cancer
4. Patients not adhering to initial thyroxine medications.
5. Those receiving proton pump inhibitory therapy, dietary fiber, bile acid sequestrates, ferrous sulfate, sucralfate, calcium carbonate, aluminum-containing antacids, phosphate binders, and raloxifene.
6. Disease interferes with thyroxine absorption, coeliac disease, inflammatory bowel disease, lactose intolerance as well as Helicobacter pylori (H. pylori) infection and atrophic gastritis,
7. Several other factors cause treatment failures such as fiber-rich food, soy protein, grapefruit, and aluminum antacids, which interfere with Thyroxine absorption. In addition to calcium carbonate and ferrous sulfate.
8. Patients were diagnosed with cardiovascular disorders, including angina, coronary artery disease, and hypertension.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Extra dose of L-thyroxine, 25 mcg during Ramadan	Hypothyroidism patients who received an increased dose of L-thyroxine, 25 mcg, n = 50

Primary Outcome Measures

Name	Time	Method
Effects of an extra dose of L-thyroxine during the month of Ramadan	3 months	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.

Trial Locations

Locations (1)

Family Promotion Centre, Endocrinology Clinic; 🇦🇪 Sharjah, United Arab Emirates