Effects of L-carnitine on Hypothyroidism

This study has been completed.
Sponsor:
Collaborator:
IlDong Pharmaceutical Co Ltd
Information provided by (Responsible Party):
Sin Gon Kim, Korea University Anam Hospital
ClinicalTrials.gov Identifier:
NCT01769157
First received: January 10, 2013
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Hypothyroidism
Drug: L-carnitine
Drug: Placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Korea University Anam Hospital:

Primary Outcome Measures:
  • Fatigue Severity scale [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    Change from Baseline in Wessely and Powell score at 12 weeks (scoring `Wessely and Powell score` at baseline and 12 weeks)


Other Outcome Measures:
  • thyroid function test [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    measure thyroid-stimulating hormone and free T4 at baseline and 12 weeks


Enrollment: 60
Study Start Date: August 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: L-carnitine
L-carnitine 330mg, 3 tablet twice daily
Drug: L-carnitine
Placebo Comparator: Placebo
placebo drug, 3 tablet twice daily
Drug: Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769157

Locations
Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Korea University Anam Hospital
IlDong Pharmaceutical Co Ltd
  More Information

No publications provided

Responsible Party: Sin Gon Kim, Professor, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT01769157     History of Changes
Other Study ID Numbers: LC-TH-1101
Study First Received: January 10, 2013
Last Updated: December 2, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases
Carnitine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014