An interventional study of Levocarnitine in Patient Compliance, sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. Status unknown at 1 site in Bangladesh. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-12-26.
Sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Not applicable, Interventional, and Treatment
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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.
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.
752 studies on the registry are indexed under Patient Compliance; 72 are open to participants now.
This study's planned enrollment of 90 is below the median of 116 across 527 interventional studies indexed under Patient Compliance.
Browse Patient Compliance studies →Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh is the lead sponsor of 128 studies on the registry; 22 are open to participants now.
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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)
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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, or malignant tumor ) viii. 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
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Control group - patients with only levothyroxine therapy
Intervention Group- Patients with levocarnitine supplementation in addition to levothyroxine therapy
Drug: Levocarnitine
Levocarnitine syrup- Oral supplementation about 2000mg/ day for 8 weeks
Also known as: Levocarnitine syrup
Fatigue score
Alleviation of fatigue level
Time frame: 8 weeks
Lipid profile
Effect of Levocarnitine on lipid level
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2017 (actual). Primary completion is estimated for Dec 2017, 9 months after the start.
Of 224 non-industry interventional studies with no phase under Patient Compliance, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 38. This study's planned 9 months is below that.
Counting every sponsor, half of 237 studies reached it within 20 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Carnitine
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh →