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Effect of Levocarnitine Supplementation for the Management of Fatigue in Levothyroxine-Treated Hypothyroid Patients

NCT ID: NCT03372772

Last Updated: 2017-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-16

Study Completion Date

2018-02-28

Brief Summary

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It has been observed that despite administration of apparently adequate thyroid hormone replacement in hypothyroid patients, many of them experience persistent fatigue and fatigue-related symptoms. Carnitine transports long chain fatty acids into the mitochondria whereupon the high energy source (ATP) becomes synthesized. Levocarnitine administration reduced fatigue related symptoms in hypothyroid patients receiving thyroid hormone replacement. The present study deals with alleviation of fatigue in hypothyroid patients by carnitine supplementation.

Detailed Description

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It has been well-established now-a-days that, some chronic diseases impose generalized weakness, lethargy, lassitude amounting from degrees mild, moderate to a severe one to total incapacitation on the part of the patients. Hypothyroid patients instate of receiving adequate thyroid hormone replacement, experience fatigue-related symptoms. Carnitine is a non-essential amino acid synthesized endogenously from essential amino acids- lysine and methionine with in the body involved in long chain fatty acid transportation to the mitochondrial membrane. Carnitine- transportation system is essential for production of energy at cellular level. Thyroid hormone plays an important role in carnitine-dependent long chain fatty acid transport and oxidation. Some available reports suggest that, Levocarnitine supplementation produced potentially favourable effects on fatigue-related symptoms in hypothyroid patients although still awaits confirmation. The present study is an attempt to investigate into the effects of Levocarnitine supplementation on fatigue in patients with hypothyroidism.

Conditions

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Patient Compliance

Keywords

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Fatigue, Levocarnitine,

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Control Group- Patients with only levothyroxine therapy Interventional Group- Patients with Levocarnitine supplementation in addition to levothyroxine therapy
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Single Blind

Study Groups

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Control group

Control group - patients with only levothyroxine therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

Intervention Group- Patients with levocarnitine supplementation in addition to levothyroxine therapy

Group Type EXPERIMENTAL

Levocarnitine

Intervention Type DRUG

Levocarnitine syrup- Oral supplementation about 2000mg/ day for 8 weeks

Interventions

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Levocarnitine

Levocarnitine syrup- Oral supplementation about 2000mg/ day for 8 weeks

Intervention Type DRUG

Other Intervention Names

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Levocarnitine syrup

Eligibility Criteria

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Inclusion Criteria

i. Clinical diagnosis of primary hypothyroidism patients with fatigue symptoms ii. Age : From 20 to 50 years iii. Levothyroxine treatment: receiving for at least 6 months iv. Serum free thyroxine level: 0.80-1.80 ng/dl v. Serum Thyroid-stimulating hormone level: 0.35-5.50 µIU/ml ( µIU = micro international unit)

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Exclusion Criteria

i. Patients with Hypothyroidism 20 years and 50 years ii. Acute or chronic liver diseases iii. Anaemia iv. Clinical diagnosis of Diabetes mellitus. v. Cardiovascular disease ( such as heart failure, arrhythmia and uncontrolled hypertension ) vi. Patients with psychological disorders (such as depression, anxiety disorder, schizophrenia, alcoholism or fatigue disorder due to other systemic diseases) vii. Patients having serious infections or terminal illness (such as tuberculosis, HIV or malignant tumor ) viii. Autoimmune diseases ( such as rheumatoid arthritis, Systemic lupus erythematosus or multiple sclerosis) ix. Patients with impaired renal function x. Pregnant or planned to be pregnant xi. Nursing mothers

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Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role lead

Responsible Party

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Dr. Farjana Akhter

Resident ( Phase-B)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Farjana Akhter, MBBS

Role: PRINCIPAL_INVESTIGATOR

Resident ,Phase-B

Locations

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Phamacology Department, BSMMU

Dhaka, Shahbag, Bangladesh

Site Status RECRUITING

Countries

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Bangladesh

Central Contacts

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Farjana Akhter, MBBS

Role: CONTACT

Phone: 01534615464

Email: [email protected]

Jasmine Dewan, PHD

Role: CONTACT

Phone: 01712533169

Facility Contacts

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Farjana Akhter, MBBS

Role: primary

Jasmine Dewan, PHD

Role: backup

Other Identifiers

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No. BSMMU/2017/2668

Identifier Type: -

Identifier Source: org_study_id