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

• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03372772
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.5
• Patients Per Site Per Month: 7.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Patient Compliance	Drug: Levocarnitine	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Control Group- Patients with only levothyroxine therapy Interventional Group- Patients with Levocarnitine supplementation in addition to levothyroxine therapyControl Group- Patients with only levothyroxine therapy Interventional Group- Patients with Levocarnitine supplementation in addition to levothyroxine therapy
• Masking: Single (Participant)
• Masking Description: Single Blind
• Primary Purpose: Treatment
• Official Title: Effect of Levocarnitine Supplementation for the Management of Fatigue in Levothyroxine-Treated Hypothyroid Patients
• Actual Study Start Date: Mar 16, 2017
• Anticipated Primary Completion Date: Dec 30, 2017
• Anticipated Study Completion Date: Feb 28, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Fatigue score [8 weeks]

   Alleviation of fatigue level

Secondary Outcome Measures

1. Lipid profile [8 weeks]

   Effect of Levocarnitine on lipid level

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 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:

1. Patients with Hypothyroidism 20 years and 50 years ii. Acute or chronic liver diseases
2. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phamacology Department, BSMMU	Dhaka	Shahbag	Bangladesh	1000

Sponsors and Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Investigators

• Principal Investigator: Farjana Akhter, MBBS, Resident ,Phase-B

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Farjana Akhter, Resident ( Phase-B), Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• ClinicalTrials.gov Identifier: NCT03372772
• Other Study ID Numbers: No. BSMMU/2017/2668
• First Posted: Dec 14, 2017
• Last Update Posted: Dec 26, 2017
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Dr. Farjana Akhter, Resident ( Phase-B), Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: Fatigue, Levocarnitine,
• Additional relevant MeSH terms: Fatigue

Study Results

No Results Posted as of Dec 26, 2017