Trial | NCT01769157  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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.
Study Started
Aug 31
2012
Primary Completion
Jun 30
2013
Study Completion
Jun 30
2013
Last Update
Dec 04
2013
Estimate

Drug L-carnitine

Drug Placebo

L-carnitine Active Comparator

L-carnitine 330mg, 3 tablet twice daily

Placebo Placebo Comparator

placebo drug, 3 tablet twice daily

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
No Results Posted