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Effects of L-carnitine on Hypothyroidism

Information source: Korea University Anam Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypothyroidism

Intervention: L-carnitine (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Korea University Anam Hospital

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.

Clinical Details

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

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

Primary outcome: Fatigue Severity scale

Secondary outcome: Wessely and Powell score

Eligibility

Minimum age: 20 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Korea University Anam Hospital, Seoul, Korea, Republic of
Additional Information

Starting date: August 2012
Last updated: December 2, 2013

Page last updated: August 23, 2015

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