Effects of L-carnitine on Hypothyroidism

Phase 4

Completed

• Conditions: Hypothyroidism
• Interventions: Drug: L-carnitine; Drug: Placebo

• Registration Number: NCT01769157
• Lead Sponsor: Korea University Anam Hospital

Brief Summary

L-carnitine and thyroid hormone tended to antagonize reciprocally in human body. Urinary excretion of L-carnitine decreased in hypothyroid patients, and levothyroxine supplementation increased excretion of L-carnitine. The investigators hypothesized that supplying L-carnitine to hypothyroid patients with fatigue symptom could improve the quality of life, and fatigue score in them. Therefore, the investigators planned to compare the efficacy of L-carnitine and placebo in hypothyroid patients who had taken levothyroxine.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-15
• Study First Posted: 2013-01-16
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-02
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Clinical diagnosis of hypothyroidism with fatigue symptom
• Currently use of the same amount of levothyroxine over at least six months
• Normal serum free T4 level

Exclusion Criteria

• Current smoker
• Serum hemoglobin level of under 12mg/dL
• Clinical diagnosis of diabetes mellitus or fasting serum glucose level ≥ 126mg/dL or HbA1c level ≥ 6.5%
• History of significant heart failure
• History of large amount of alcohol consumption
• Uncontrolled hypertension (systolic blood pressure ≥ 160 millimeter of mercury (mmHg) or diastolic blood pressure ≥ 100 mmHg
• pregnant, or planning to be pregnant, or breast feeding women
• aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 times of normal limit
• serum Cr level > 2.0mg/dL

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-carnitine	L-carnitine	L-carnitine 330mg, 3 tablet twice daily
Placebo	Placebo	placebo drug, 3 tablet twice daily

Primary Outcome Measures

Name	Time	Method
Fatigue Severity scale	baseline and 12 weeks	Change from Baseline in Fatigue severity scale at 12 weeks (scoring 'fatigue severity scale' at baseline and 12 weeks)

Secondary Outcome Measures

Name	Time	Method
Wessely and Powell score	baseline and 12 weeks	Change from Baseline in Wessely and Powell score at 12 weeks (scoring 'Wessely and Powell score' at baseline and 12 weeks)

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of