An interventional study of L-carnitine and Placebo in Obstructive Sleep Apnea, sponsored by Poznan University of Medical Sciences. Withdrawn. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-05-06.
Sponsored by Poznan University of Medical Sciences · Not applicable, Interventional, and Treatment
The investigators designed this intervention to investigate the potential role of L-C in lipid and carbohydrates metabolism (primary outcome) with precision noninvasively measurement of: central blood pressure, pulse wave velocity and peripheral arterial stiffness (secondary outcome) in OSA patients.
After screening all patients will be randomized in 1:1 ratio to either placebo group or study group (receiving L-C for 8-weeks). Randomization will stratify patients by: age, sex, BMI and severity of OSA. Randomized patients will receive orally either placebo or L-C once a day for 8-weeks. All supplements will be packed in a white box. Because this is a double-blind study, vial labels will contain a unique identification number that will not disclose to the patient or investigator if L-C or matching placebo is included. The daily amount of L-C will be 1400 mg. The detailed composition of the product will be assessed. All patients will receive a test product during the control visits once a month and will be asked to take it once a day in the morning. The completion of the data will be checked during the visits and also via telephone while the study is conducted. All concomitant medications used (including herbal supplements) will be recorded in electronic database. The patients will be asked to continue their habitual diet. Moreover, they will be also advised that they are free to withdraw from participation in this study at any time, for any reason, and without prejudice. The reason for withdrawal and the date of discontinuation will be recorded in our database. Any Adverse Event (AE) will be recorded according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE), clinically significant AE, severe laboratory abnormality, intercurrent illness, or other medical condition that indicates that continued administration of study medication is not in the best interest of the patient.
The treatment will be administrated under supervision of experienced nutritionist and medical doctor. The anthropometrical and biochemical measurements with assessment of diet, quality of life and sleep will be completed by the patients at each of the study visits, which will take place at the baseline (screening visit), after 4 weeks, in the post-intervention period (week 8) and at a 6-month follow-up.
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
Browse Sleep Apnea, Obstructive studies →Poznan University of Medical Sciences is the lead sponsor of 147 studies on the registry; 45 are open to participants now.
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Exclusion Criteria:
L-carnitine 1400 mg daily for 8 weeks
Dietary Supplement: L-carnitine
Placebo
Dietary Supplement: Placebo
L-carnitine 1400 mg daily for 8 weeks
Placebo daily for 8 weeks
Changes in Total cholesterol, LDL cholesterol, HDL cholesterol and Triglycerides concentration
Time frame: 6 months
Changes in fasting glucose concentration
Time frame: 6 months
Changes in insulin concentration
Time frame: 6 months
Changes in central blood pressure
Time frame: 6 months
Changes in pulse wave velocity
Time frame: 6 months
Changes in peripheral arterial stiffness
Time frame: 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2020; primary completion for Dec 2020, 4 months later.
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This study is withdrawn, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Carnitine
Poznan University of Medical Sciences →