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

Primary Purpose

Patient Compliance

Status

Unknown status

Phase

Not Applicable

Locations

Bangladesh

Study Type

Interventional

Intervention

Levocarnitine

About this trial

This is an interventional treatment trial for Patient Compliance focused on measuring Fatigue, Levocarnitine,

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Phamacology Department, BSMMURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Intervention group

Arm Description

Control group - patients with only levothyroxine therapy

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

Outcomes

Primary Outcome Measures

Fatigue score

Alleviation of fatigue level

Secondary Outcome Measures

Lipid profile

Effect of Levocarnitine on lipid level

Full Information

NCT ID

NCT03372772

First Posted

December 10, 2017

Last Updated

December 21, 2017

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

1. Study Identification

Unique Protocol Identification Number

NCT03372772

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Unknown status

Study Start Date

March 16, 2017 (Actual)

Primary Completion Date

December 30, 2017 (Anticipated)

Study Completion Date

February 28, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patient Compliance

Keywords

Fatigue, Levocarnitine,

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Participant

Masking Description

Single Blind

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Control group - patients with only levothyroxine therapy

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Levocarnitine

Other Intervention Name(s)

Levocarnitine syrup

Intervention Description

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

Primary Outcome Measure Information:

Title

Fatigue score

Description

Alleviation of fatigue level

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Lipid profile

Description

Effect of Levocarnitine on lipid level

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Farjana Akhter, MBBS

Phone

01534615464

polynoble@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jasmine Dewan, PHD

Phone

01712533169

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Farjana Akhter, MBBS

Organizational Affiliation

Resident ,Phase-B

Official's Role

Principal Investigator

Facility Information:

Facility Name

Phamacology Department, BSMMU

City

Dhaka

State/Province

Shahbag

ZIP/Postal Code

1000

Country

Bangladesh

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Farjana Akhter, MBBS

Phone

01534615464

polynoble@gmail.com

First Name & Middle Initial & Last Name & Degree

Jasmine Dewan, PHD

Phone

01712533169

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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