Back to resultsEffects of L-carnitine on Hypothyroidism
Primary Purpose
Hypothyroidism
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
L-carnitine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypothyroidism
Eligibility 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
Sites / Locations
- Korea University Anam Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
L-carnitine
Placebo
Arm Description
L-carnitine 330mg, 3 tablet twice daily
placebo drug, 3 tablet twice daily
Outcomes
Primary Outcome Measures
Fatigue Severity scale
Change from Baseline in Fatigue severity scale at 12 weeks (scoring 'fatigue severity scale' at baseline and 12 weeks)
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT01769157
First Posted
January 10, 2013
Last Updated
December 2, 2013
Sponsor
Korea University Anam Hospital
Collaborators
IlDong Pharmaceutical Co Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01769157
Brief Title
Effects of L-carnitine on Hypothyroidism
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 Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Anam Hospital
Collaborators
IlDong Pharmaceutical Co Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
L-carnitine
Arm Type
Active Comparator
Arm Description
L-carnitine 330mg, 3 tablet twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo drug, 3 tablet twice daily
Intervention Type
Drug
Intervention Name(s)
L-carnitine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Fatigue Severity scale
Description
Change from Baseline in Fatigue severity scale at 12 weeks (scoring 'fatigue severity scale' at baseline and 12 weeks)
Time Frame
baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Wessely and Powell score
Description
Change from Baseline in Wessely and Powell score at 12 weeks (scoring 'Wessely and Powell score' at baseline and 12 weeks)
Time Frame
baseline and 12 weeks
Other Pre-specified Outcome Measures:
Title
thyroid function test
Description
measure thyroid-stimulating hormone and free T4 at baseline and 12 weeks
Time Frame
baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
27432821
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of L-carnitine on Hypothyroidism
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