Status:
COMPLETED
Impact of Increasing Levothyroxine Dose in Ramadan for UAE Patients With Hypothyroidism
Lead Sponsor:
Emirates Health Services (EHS)
Collaborating Sponsors:
University of Sharjah
Conditions:
L-thyroxine
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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...
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, Endocrino...
Eligibility Criteria
Inclusion
- The inclusion criteria for participants will include:
- Male and female patients with primary hypothyroidism.
- Patients with stable TSH
- Aged between 18 and 70 years.
- Patients regularly fasting for at least 25- 30 days during Ramadan.
- Emirati nationals (100% health care coverage)
- Exclusion Criteria:
- Patients with any end organ damage
- Pregnant or Breast-feeding women
- Thyroid cancer
- Patients not adhering to initial thyroxine medications.
- Those receiving proton pump inhibitory therapy, dietary fiber, bile acid sequestrates, ferrous sulfate, sucralfate, calcium carbonate, aluminum-containing antacids, phosphate binders, and raloxifene.
- Disease interferes with thyroxine absorption, coeliac disease, inflammatory bowel disease, lactose intolerance as well as Helicobacter pylori (H. pylori) infection and atrophic gastritis,
- 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.
- Patients were diagnosed with cardiovascular disorders, including angina, coronary artery disease, and hypertension.
Exclusion
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2022
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT06135948
Start Date
March 15 2022
End Date
June 15 2022
Last Update
November 18 2023
Active Locations (1)
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1
Family Promotion Centre, Endocrinology Clinic
Sharjah city, United Arab Emirates