- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03372772
Effect of Levocarnitine Supplementation for the Management of Fatigue in Levothyroxine-Treated Hypothyroid Patients
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Farjana Akhter, MBBS
- Phone Number: 01534615464
- Email: polynoble@gmail.com
Study Contact Backup
- Name: Jasmine Dewan, PHD
- Phone Number: 01712533169
Study Locations
-
-
Shahbag
-
Dhaka, Shahbag, Bangladesh, 1000
- Recruiting
- Phamacology Department, BSMMU
-
Contact:
- Farjana Akhter, MBBS
- Phone Number: 01534615464
- Email: polynoble@gmail.com
-
Contact:
- Jasmine Dewan, PHD
- Phone Number: 01712533169
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
|
Levocarnitine syrup- Oral supplementation about 2000mg/ day for 8 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatigue score
Time Frame: 8 weeks
|
Alleviation of fatigue level
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lipid profile
Time Frame: 8 weeks
|
Effect of Levocarnitine on lipid level
|
8 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Farjana Akhter, MBBS, Resident ,Phase-B
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- No. BSMMU/2017/2668
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patient Compliance
-
HaEmek Medical Center, IsraelUnknownPatient Satisfaction | Patient Compliance
-
University of AarhusUnknownPatient Engagement | Patient Empowerment | Patient Compliance
-
University of Illinois at Urbana-ChampaignNational Institute on Aging (NIA)Completed
-
Coloplast A/SCompletedCompliance, PatientDenmark
-
Arizona State UniversityNational Institute on Drug Abuse (NIDA); Mesa Public SchoolsCompletedPatient ComplianceUnited States
-
Norwegian Medical AssociationCompleted
-
Xijing Hospital of Digestive DiseasesRecruiting
-
Shara Qadir HusseinCompleted
-
University of CalgaryCompleted
-
Mansoura UniversityCompleted
Clinical Trials on Levocarnitine
-
Lee's Pharmaceutical LimitedCompleted
-
Vanderbilt University Medical CenterRecruitingKeratoconjunctivitis Sicca | Sjogren's SyndromeUnited States
-
The First Affiliated Hospital of Zhejiang Chinese...Not yet recruiting
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)CompletedFatigue | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Bangabandhu Sheikh Mujib Medical University, Dhaka...Unknown
-
Children's Hospital of Orange CountyUniversity of California, IrvineRecruitingAcute Lymphoblastic Leukemia | HepatotoxicityUnited States
-
Montefiore Medical CenterThe Gerber FoundationCompletedPrematurity | Neurodevelopmental Disorder | Carnitine DeficiencyUnited States
-
Karen Lindhardt MadsenRigshospitalet, DenmarkCompletedCarnitine Transporter, Plasma-membrane, Deficiency of
-
Maastricht University Medical CenterCompleted
-
Dr. Amer JohriQueen's University; Heart and Stroke Foundation of CanadaCompleted