Objective: The aim of the current study is to evaluate the effects of carnitine supplementation on metabolic profiles in women with polycystic ovary syndrome (PCOS). Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Inclusion and exclusion criteria: In the current study, women aged 18-40 years diagnosed with PCOS will be included. Individuals with neoplastic, cardiovascular disorders, malabsorptive disorders, current or previous (within the last 6 months) use of hormonal, anti-diabetic medications and anti-obesity medications will be excluded in the study. Population and sample size: 60 patients with PCOS among women of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either carnitine supplements (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12 weeks of intervention to measure metabolic profiles. Start and end date of intervention: 12 weeks. Outcomes: Metabolic profiles will be measured at study baseline and after 12 weeks of intervention
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508025623N49
Registration date:2015-08-25, 1394/06/03
Registration timing:retrospective
Last update:
Update count:1
Registration date
2015-08-25, 1394/06/03
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2015-06-03, 1394/03/13
Expected recruitment end date
2015-06-13, 1394/03/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of carnitine supplementation on metabolic profiles in women with polycystic ovary syndrome
Public title
Effect of supplementation in treatment of women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women aged 18-40 years; diagnosed with PCOS.
Exclusion criteria: Individuals with neoplastic; cardiovascular disorders; malabsorptive disorders; current or previous (within the last 6 months) use of hormonal; anti-diabetic medications; anti-obesity medications.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak