Evening versus Morning Administration of Levothyroxine: a randomised controlled double-blind trial

Phase 4

• Conditions: Hypothyroidism; slow thyroid; 10043739

• Registration Number: NL-OMON30653
• Lead Sponsor: Medisch Centrum Rijnmond-Zuid

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Age > 18 years
At least 6 months on a stable regimen of levothyroxine, with TSH 0.4-4.0 mU/l

Exclusion Criteria

Pregnancy
Disease of the stomach, jejunum or ileum
Use of medication known to interfer with the uptake of levothyroxine

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint will be a significant change in TSH and thyroid hormones<br /><br>FT4/T3 with a switch to the bedtime administration of levothyroxine compared to<br /><br>the morning administration. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary endpoints will be a change in blood pressure, pulse, weight, other<br /><br>lab results (ferritin, albumin, lipids etc.), a change in quality of life and<br /><br>symptoms of hypo-or hyperthyroidism. Furthermore we will study if patients that<br /><br>were subclinically hypothyroid, and become euthyroid or (subclinically)<br /><br>hyperthyroid because of the different administration time of levothyroxine,<br /><br>have a change in quality of life.</p><br>