HypothyroidismPhase 4NCT01769157
Effects of L-carnitine on Hypothyroidism
A Phase 4 study testing L-carnitine in people with Hypothyroidism, run by Korea University Anam Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- L-carnitine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Jun 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Single-center, Randomized, Double-Blinded, Comparative Study of the Effectiveness of L-carnitine in Patients'Fatigue Degree Changing With Hypothyroidism Who Take Levothyroxine
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.
- Conditions
- Hypothyroidism
- Being tested
- L-carnitine, Placebo
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-carnitineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| L-carnitine | Active comparator | L-carnitine 330mg, 3 tablet twice daily Receives: Drug: L-carnitine |
| Placebo | Placebo comparator | placebo drug, 3 tablet twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity scale
Change from Baseline in Fatigue severity scale at 12 weeks (scoring 'fatigue severity scale' at baseline and 12 weeks)
Measured: baseline and 12 weeks
Secondary outcomes (1)
Wessely and Powell score
Change from Baseline in Wessely and Powell score at 12 weeks (scoring 'Wessely and Powell score' at baseline and 12 weeks)
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startAug 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- IlDong Pharmaceutical Co Ltd
- Responsible party
- Principal investigator, Sin Gon Kim, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769157
- Sponsor's protocol ID
- LC-TH-1101
- Status last verified
- Dec 2013
- First submitted
- 10 Jan 2013
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27432821
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Randomized, Double-Blinded, Comparative Study of the Effectiveness of L-carnitine in Patients'Fatigue Degree Changing With Hypothyroidism Who Take Levothyroxine
- ClinicalTrials.gov ID
- NCT01769157
- Acronym / sponsor ID
- LC-TH-1101
- Conditions
- Hypothyroidism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- IlDong Pharmaceutical Co Ltd
- Study start
- Aug 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-carnitine | Active comparator | Drug: L-carnitineL-carnitine 330mg, 3 tablet twice daily |
| Placebo | Placebo comparator | Drug: Placeboplacebo drug, 3 tablet twice daily |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-carnitine | Drug | L-carnitine |
| Placebo | Drug | Placebo |
Primary outcome
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)
1 secondary outcome
Wessely and Powell score
Time frame: baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
- Derived from this study: PubMed 27432821An 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing L-carnitine in people with Hypothyroidism, run by Korea University Anam Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity scale (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01769157, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2013.