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Effects of L-carnitine on Hypothyroidism

K

Korea University

Status and phase

Completed
Phase 4

Conditions

Hypothyroidism

Treatments

Drug: Placebo
Drug: L-carnitine

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01769157
LC-TH-1101

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups, including a placebo group

L-carnitine
Active Comparator group
Description:
L-carnitine 330mg, 3 tablet twice daily
Treatment:
Drug: L-carnitine
Placebo
Placebo Comparator group
Description:
placebo drug, 3 tablet twice daily
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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