Effects of L-carnitine on Hypothyroidism

NCT ID: NCT01769157

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Hypothyroidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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L-carnitine

L-carnitine 330mg, 3 tablet twice daily

Group Type ACTIVE_COMPARATOR

L-carnitine

Intervention Type DRUG

Placebo

placebo drug, 3 tablet twice daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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L-carnitine

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IlDong Pharmaceutical Co Ltd

INDUSTRY

Sponsor Role collaborator

Korea University Anam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sin Gon Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Korea University Anam Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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An JH, Kim YJ, Kim KJ, Kim SH, Kim NH, Kim HY, Kim NH, Choi KM, Baik SH, Choi DS, Kim SG. L-carnitine supplementation for the management of fatigue in patients with hypothyroidism on levothyroxine treatment: a randomized, double-blind, placebo-controlled trial. Endocr J. 2016 Oct 29;63(10):885-895. doi: 10.1507/endocrj.EJ16-0109. Epub 2016 Jul 16.

Reference Type DERIVED
PMID: 27432821 (View on PubMed)

Other Identifiers

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LC-TH-1101

Identifier Type: -

Identifier Source: org_study_id