Comparison of the effect of oral L-carnitine and placebo supplementation on anthropometric indices, lipid status, insulin and hormone resistance indices in obese / overweight women suffering from polycystic ovary syndrome
To evaluate the effect of weight loss regimen with and without L- carnitine supplementation on lipids, insulin and hormone resistance indices in women in reproductive age with polycystic ovary syndrome and overweight/obesity.
Design
A randomized, double blinded, controlled clinical trial with a sample size of 62 patients. Enrollment will be done between October 2019 and January 2020
Settings and conduct
The study was conducted at Yazd Diabetes Center. In order to do blinding, drugs were packed in separate envelopes without informing patients and researchers.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-45 year-old women referred to Kashan Naghavi Hospital; Polycystic Ovarian Syndrome based on Rotterdam Diagnostic Criteria; Body Mass Index 25 and over; Interested to participate in study.
Non-inclusion criteria: smoking; diabetes or thyroid disease; people who have been on a special diet for the past three months or have used a weight-loss drug, hormone, and ovulation stimulant.
Intervention groups
The intervention group should take a daily dose of 1000 mg carnitine capsules with lunch and the placebo group should use capsules which are exactly as same as carnitine capsules in the shape and color but without any active ingredient. Both groups will use the capsules for 12 weeks.
Comparison of the effect of oral L-carnitine and placebo supplementation on anthropometric indices, lipid status, insulin and hormone resistance indices in obese / overweight women suffering from polycystic ovary syndrome
Public title
The effect of oral L-carnitine supplementation on polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-45 years old women referred to Yazd Diabetes Center
Polycystic ovary syndrome based on Rotterdam diagnostic criteria
Body Mass Index 25 and over
interested in participation in the study
Taking usual treatment of PCOS
Exclusion criteria:
Smoking
Suffering from diabetes or thyroid disease
Having a special diet for the past three months
Weight-loss medication, hormone or ovulation stimulant use
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation tables
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding the researcher and participants.
For this purpose the tablets were initially packaged in two packages A and B.The nature of the tablets will remain hidden from the participants and researchers until after the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Central Building of Shahid Sadoughi University of Medical Sciences, Bahonar Square
City
Yazd
Province
Yazd
Postal code
8715113514
Approval date
2018-05-22, 1397/03/01
Ethics committee reference number
IR.SSU.SPH.REC.1397.014
Health conditions studied
1
Description of health condition studied
Polycystic Ovarian Syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic Ovarian Syndrome
Primary outcomes
1
Description
Insulin
Timepoint
At the beginning and at the end of the study (120 days later)
Method of measurement
Insulin Kit
2
Description
fasting blood sugar
Timepoint
At the beginning and at the end of the study (120 days later)
Method of measurement
Blood test
3
Description
Sex hormone-binding globulin
Timepoint
At the beginning and at the end of the study (120 days later)
Method of measurement
kit
4
Description
triglyceride
Timepoint
At the beginning and at the end of the study (120 days after)
Method of measurement
Blood test
5
Description
Cholesterol
Timepoint
At the beginning and at the end of the study (120 days later)
Method of measurement
Blood test
6
Description
HDL
Timepoint
At the beginning and at the end of the study (120 days later)
Method of measurement
Blood test
7
Description
LDL
Timepoint
At the beginning and at the end of the study (120 days later)
Method of measurement
Blood test
8
Description
HOMA IR
Timepoint
At the beginning and at the end of the study (120 days later)
Method of measurement
By formula using fasting glucose and insulin
Secondary outcomes
empty
Intervention groups
1
Description
Control group: receiving placebo containing non-active substance for 12 weeks
Category
Placebo
2
Description
Intervention group: Oral administration of L-carnitine supplement 1000 mg daily for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Diabetes Research Center
Full name of responsible person
Dr.Nasim Namiranian
Street address
At the end of Talare Honar Alley, Shahid Sadoughi Boulevard, from Bahonar Square to Azadi Square
City
Yazd
Province
Yazd
Postal code
8715113514
Phone
+98 35 3728 0226
Email
diabet_center@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Hassan Ehrampoosh
Street address
School of Public Health, Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam Boulevard, Alam Square, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۶۰
Phone
+98 35 3820 9100
Email
ravabet.odb@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Pakravanfar
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Alem square
City
Yazd
Province
Yazd
Postal code
8715113514
Phone
+98 31 5557 3812
Fax
Email
fatemeh.p1993@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Pakravanfar
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Alem square
City
yazd
Province
Yazd
Postal code
8715113514
Phone
+98 31 5557 3812
Fax
Email
fatemeh.p1993@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Pakravanfar
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Alem square
City
yazd
Province
Yazd
Postal code
8715113514
Phone
+98 31 5557 3812
Fax
Email
fatemeh.p1993@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available