NCT01769157

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 16, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

December 4, 2013

Status Verified

December 1, 2013

Enrollment Period

10 months

First QC Date

January 10, 2013

Last Update Submit

December 2, 2013

Conditions

Hypothyroidism

Outcome Measures

Primary Outcomes (1)

  • Fatigue Severity scale

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

    baseline and 12 weeks

Secondary Outcomes (1)

  • Wessely and Powell score

    baseline and 12 weeks

Other Outcomes (1)

  • thyroid function test

    baseline and 12 weeks

Study Arms (2)

L-carnitine

ACTIVE COMPARATOR

L-carnitine 330mg, 3 tablet twice daily

Drug: L-carnitine

Placebo

PLACEBO COMPARATOR

placebo drug, 3 tablet twice daily

Drug: Placebo

Interventions

L-carnitineDRUG
L-carnitine
PlaceboDRUG
Placebo

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anam Hospital

Seoul, South Korea

Location

Related Publications (1)

  • An JH, Kim YJ, Kim KJ, Kim SH, Kim NH, Kim HY, Kim NH, Choi KM, Baik SH, Choi DS, Kim SG. L-carnitine supplementation for the management of fatigue in patients with hypothyroidism on levothyroxine treatment: a randomized, double-blind, placebo-controlled trial. Endocr J. 2016 Oct 29;63(10):885-895. doi: 10.1507/endocrj.EJ16-0109. Epub 2016 Jul 16.

    PMID: 27432821DERIVED

MeSH Terms

Conditions

Hypothyroidism

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 10, 2013

First Posted

January 16, 2013

Study Start

August 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

December 4, 2013

Record last verified: 2013-12

Locations

KR(1)