Study Results
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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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2012-08-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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L-carnitine
L-carnitine 330mg, 3 tablet twice daily
L-carnitine
Placebo
placebo drug, 3 tablet twice daily
Placebo
Interventions
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L-carnitine
Placebo
Eligibility Criteria
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Inclusion Criteria
* Currently use of the same amount of levothyroxine over at least six months
* Normal serum free T4 level
Exclusion Criteria
* 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
20 Years
70 Years
ALL
No
Sponsors
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IlDong Pharmaceutical Co Ltd
INDUSTRY
Korea University Anam Hospital
OTHER
Responsible Party
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Sin Gon Kim
Professor
Locations
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Korea University Anam Hospital
Seoul, , South Korea
Countries
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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.
Other Identifiers
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LC-TH-1101
Identifier Type: -
Identifier Source: org_study_id