evothyroxine treatment during Ramada

Not Applicable

Completed

• Conditions: Hypothyroidism; Nutritional, Metabolic, Endocrine; Hypothyroidism, unspecified

• Registration Number: ISRCTN54141719
• Lead Sponsor: Cleveland Clinic Abu Dhabi

Brief Summary

2021 Results article in https://doi.org/10.1159/000517706 (added 22/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-07-15
• Study Start: 2021-02-17
• Last Update Posted: 5 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

1. Age 18 years or older
2. Hypothyroidism treated with levothyroxine for over 6 months
3. Planning to fast during the month of Ramadan
3. Ability to provide informed consent

Exclusion Criteria

1. Age less than 18 years
2. Inability to provide an informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Thyroid function tests (plasma TSH and free-T4) measured on the Roche e601 immunoassay analyzer using the electrochemiluminescence immunoassay (ECLIA) sandwich principle for TSH and the ECLIA competition principle for free-T4, within 3 months before Ramadan and repeated within 6 weeks post-Ramadan

Secondary Outcome Measures

Name	Time	Method
<br> 1. The impact of age and gender on the primary outcome measure, change in thyroid function tests (see above) from pre-to post-Ramadan<br> 2. Patient compliance and satisfaction with the assigned randomized treatment assessed with a telephone call to each patient at the end of the study<br>