NCT02645942

L-carnitine for Reducing Cardio-metabolic Risk in Patients With Obstructive Sleep Apnea

L-carnitine for Reducing Cardio-metabolic Risk in Patients With Obstructive Sleep Apnea - Double Blind Randomized Clinical Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Poznan University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	L-carnitine	L-carnitine 1400 mg daily for 8 weeks
DIETARY_SUPPLEMENT	Placebo	Placebo daily for 8 weeks

Timeline

• Start date: 2020-08-01
• Primary completion: 2020-12-01
• Completion: 2021-02-01
• First posted: 2016-01-05
• Last updated: 2020-05-06