Effects of L-carnitine on Hypothyroidism

Hypothyroidism Clinical Trial

Official title:

Single-center, Randomized, Double-Blinded, Comparative Study of the Effectiveness of L-carnitine in Patients'Fatigue Degree Changing With Hypothyroidism Who Take Levothyroxine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01769157
• Other study ID #: LC-TH-1101
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2013
• Last updated: December 2, 2013
• Start date: August 2012
• Est. completion date: June 2013

Study information

• Verified date: December 2013
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypothyroidism

Intervention

Drug:
• L-carnitine

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Anam Hospital	IlDong Pharmaceutical Co Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	thyroid function test	measure thyroid-stimulating hormone and free T4 at baseline and 12 weeks	baseline and 12 weeks	No
Primary	Fatigue Severity scale	Change from Baseline in Fatigue severity scale at 12 weeks (scoring `fatigue severity scale` at baseline and 12 weeks)	baseline and 12 weeks	Yes
Secondary	Wessely and Powell score	Change from Baseline in Wessely and Powell score at 12 weeks (scoring `Wessely and Powell score` at baseline and 12 weeks)	baseline and 12 weeks	Yes