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Completed

NCT Number: NCT01769157

Effects of L-carnitine on Hypothyroidism

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.

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Key information

Conditions

Hypothyroidism Endocrine System Diseases Thyroid Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Korea University Anam Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-carnitine

Drug

Placebo

Drug

Primary outcomes

  1. Fatigue Severity scale

    Time frame: baseline and 12 weeks

    Change from Baseline in Fatigue severity scale at 12 weeks (scoring 'fatigue severity scale' at baseline and 12 weeks)

Secondary outcomes

  1. Wessely and Powell score

    Time frame: baseline and 12 weeks

    Change from Baseline in Wessely and Powell score at 12 weeks (scoring 'Wessely and Powell score' at baseline and 12 weeks)

Other outcomes

  1. thyroid function test

    Time frame: baseline and 12 weeks

    measure thyroid-stimulating hormone and free T4 at baseline and 12 weeks

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Collaborators

  • IlDong Pharmaceutical Co Ltd

Registry information

Official study title

Single-center, Randomized, Double-Blinded, Comparative Study of the Effectiveness of L-carnitine in Patients'Fatigue Degree Changing With Hypothyroidism Who Take Levothyroxine

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 16, 2013
Registry last updated
Dec 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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