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

NCT03372772 | Unknown

• 1 other identifier: No. BSMMU/2017/2668
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Compliance

Keywords

Fatigue, Levocarnitine,

Outcome Measures

Primary Outcomes (1)

• Fatigue score

  Alleviation of fatigue level

  8 weeks

Secondary Outcomes (1)

• Lipid profile

  8 weeks

Study Arms (2)

Control group

NO INTERVENTION

Control group - patients with only levothyroxine therapy

Intervention group

EXPERIMENTAL

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

Drug: Levocarnitine

Interventions

Levocarnitine DRUG

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

Also known as: Levocarnitine syrup

Intervention group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Phamacology Department, BSMMU

Dhaka, Shahbag, 1000, Bangladesh

RECRUITING

MeSH Terms

Conditions

Patient Compliance; Fatigue

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Farjana Akhter, MBBS

  Resident ,Phase-B

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farjana Akhter, MBBS

CONTACT

01534615464; polynoble@gmail.com

Jasmine Dewan, PHD

CONTACT

01712533169

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident ( Phase-B)

Model Details: Control Group- Patients with only levothyroxine therapy Interventional Group- Patients with Levocarnitine supplementation in addition to levothyroxine therapy

Study Record Dates

• First Submitted: December 10, 2017
• First Posted: December 14, 2017
• Study Start: March 16, 2017
• Primary Completion: December 30, 2017
• Study Completion: February 28, 2018
• Last Updated: December 26, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)