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

Study Overview
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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.

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

Conditions
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Patient Compliance

Intervention / Treatment
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* Drug: Levocarnitine


Participation Criteria
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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) - 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 -

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control Group- Patients with only levothyroxine therapy Interventional Group- Patients with Levocarnitine supplementation in addition to levothyroxine therapy
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Control group - patients with only levothyroxine therapy | |
| Experimental: Intervention group<br>Intervention Group- Patients with levocarnitine supplementation in addition to levothyroxine therapy | Drug: Levocarnitine<br>* Levocarnitine syrup- Oral supplementation about 2000mg/ day for 8 weeks<br>* Other names: Levocarnitine syrup;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue score | Alleviation of fatigue level | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile | Effect of Levocarnitine on lipid level | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue, Levocarnitine,