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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01769157
Enrollment
60
Registered
2013-01-16
Start date
2012-08-31
Completion date
2013-06-30
Last updated
2013-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothyroidism

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.

Interventions

DRUGL-carnitine
DRUGPlacebo

Sponsors

IlDong Pharmaceutical Co Ltd
CollaboratorINDUSTRY
Korea University Anam Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fatigue Severity scalebaseline and 12 weeksChange from Baseline in Fatigue severity scale at 12 weeks (scoring 'fatigue severity scale' at baseline and 12 weeks)

Secondary

MeasureTime frameDescription
Wessely and Powell scorebaseline and 12 weeksChange from Baseline in Wessely and Powell score at 12 weeks (scoring 'Wessely and Powell score' at baseline and 12 weeks)

Other

MeasureTime frameDescription
thyroid function testbaseline and 12 weeksmeasure thyroid-stimulating hormone and free T4 at baseline and 12 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026