IRCT | Effects of folic acid supplementation on insulin resistance and inflammatory factor in overweight women with polycystic ovary syndrome

Protocol summary

Study aim: Objective: The aim of this study is to determine the effects of folic acid supplementation on insulin resistance and inflammatory factor in overweight women with polycystic ovary syndrome (PCOS).
Design: Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers.
Settings and conduct: Population and sample size: Among patients with PCOS referred to Emam Reza and Taleghani Clinics affiliated to Arak University of Medical Sciences and Naghavi Clinic affiliated to Kashan University of Medical Sciences, 81 patients will be selected according to inclusion and eclusion criteria.
Participants/Inclusion and exclusion criteria: Inclusion criteria: Women aged 18-40 years diagnosed with PCOS. Exclusion criteria:Women aged<18 or >40 years, those with BMI<25 kg/m2, individuals with neoplastic, hepatic, renal and cardiovascular disorders, malabsorptive disorders, current or previous (within the last 6 months) use of hormonal, antidiabetic medications, anti-obesity medications, intention to adopt a diet and/or a specific physical activity program.
Intervention groups: Intervention: Patients will be assigned to receive either 1 mg folic acid supplement (intervention group: n=27), 5 mg folic acid supplement (intervention group: n=27) or placebo (control group: n=27).
Main outcome variables: Outcomes: Markers of insulin metabolism and hormonal profiles (primary outcomes) and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.

General information

Reason for update: Due to an error, the request for an update in our website was conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
Acronym
IRCT registration information: IRCT registration number: IRCT201306085623N8

Registration date: 2013-06-20, 1392/03/30

Registration timing: registered_while_recruiting

Last update: 2019-10-31, 1398/08/09

Update count: 1
Registration date: 2013-06-20, 1392/03/30

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: 2013-06-04, 1392/03/14
Expected recruitment end date: 2013-07-04, 1392/04/13
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Effects of folic acid supplementation on insulin resistance and inflammatory factor in overweight women with polycystic ovary syndrome

Public title: Effect of supplementation in treatment of polycystic ovary syndrome
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Women aged 18-40 years diagnosed with PCOS

Exclusion criteria:

Women aged<18 or >40 years Those with BMI<25 kg/m2, individuals with neoplastic, hepatic, renal and cardiovascular disorders Malabsorptive disorders Current or previous (within the last 6 months) use of hormonal Antidiabetic medications Anti-obesity medications Intention to adopt a diet and/or a specific physical activity program
Age: From 18 years old to 40 years old
Gender: Female

Phase

N/A

Groups that have been masked

Participant
Investigator
Outcome assessor

Sample size

Target sample size: 81

Randomization (investigator's opinion)

Randomized

Randomization description

At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take folate 1 mg (n=27), folate 5 mg (n=27) and placebo (n=27). Randomization will be done by the use of computer-generated random numbers.

Blinding (investigator's opinion)

Double blinded

Blinding description

Participants, investigators or the assessors of the outcomes are unaware of the study groups.

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 Education and Research, Sardasht Avenue, Arak

City

Arak

Province

Markazi

Postal code

3814113634
Approval date: 2013-06-03, 1392/03/13
Ethics committee reference number: 92-147-9

Health conditions studied

1

Description of health condition studied: Polycystic ovary syndrome
ICD-10 code: E28.2
ICD-10 code description: Sclerocystic ovary syndrome Stein-Leventhal syndrome

Primary outcomes

1

Description: Insulin
Timepoint: At the beginning of the study and after 8 weeks of intervention
Method of measurement: Elisa

2

Description: Hs-CRP
Timepoint: At the beginning of the study and after 8 weeks of intervention
Method of measurement: Elisa

Secondary outcomes

1

Description: Insulin resistance
Timepoint: At the beginning of the study and after 8 weeks of intervention
Method of measurement: Questionnaire

2

Description: Triglycerides
Timepoint: At the beginning of the study and after 8 weeks of intervention
Method of measurement: Enzymatic kit

3

Description: Total cholesterol
Timepoint: At the beginning of the study and after 8 weeks of intervention
Method of measurement: Enzymatic kit

4

Description: HDL
Timepoint: At the beginning of the study and after 8 weeks of intervention
Method of measurement: Enzymatic kit

5

Description: VLDL
Timepoint: At the beginning of the study and after 8 weeks of intervention
Method of measurement: Enzymatic kit

6

Description: LDL
Timepoint: At the beginning of the study and after 8 weeks of intervention
Method of measurement: Enzymatic kit

7

Description: FPG
Timepoint: At the beginning of the study and after 8 weeks of intervention
Method of measurement: Enzymatic kit

8

Description: Total antioxidant
Timepoint: At the beginning of the study and after 8 weeks of intervention
Method of measurement: Spectrophotometry

9

Description: Glutathione
Timepoint: At the beginning of the study and after 8 weeks of intervention
Method of measurement: Spectrophotometry

10

Description: Malondialdehyde
Timepoint: At the beginning of the study and after 8 weeks of intervention
Method of measurement: Spectrophotometry

11

Description: Nitric oxide
Timepoint: At the beginning of the study and after 8 weeks of intervention
Method of measurement: Spectrophotometry

12

Description: Catalase
Timepoint: At the beginning of the study and after 8 weeks of intervention
Method of measurement: Spectrophotometry

Intervention groups

1

Description: Intervention group: Folic acid tablet, 1 mg, daily, for 8 weeks orally.
Category: Treatment - Drugs

2

Description: Intervention group: Folic acid tablet, 5 mg, daily, for 8 weeks orally.
Category: Treatment - Drugs

3

Description: Control group: Placebo tablet, daily, for 8 weeks orally.
Category: Treatment - Drugs

Recruitment centers

1

Recruitment center: Name of recruitment center

Emam Reza and Taleghani Clinics

Full name of responsible person

Maryam Karamali

Street address

Emam Khomeyni Avenue, Arak

City

Arak

Province

Markazi

Postal code

3814113634

Phone

+98 86 3223 3823

Email

karamali.maryam2@gmail.com

2

Recruitment center: Name of recruitment center

Naghavi Clinic

Full name of responsible person

Zatollah Asemi

Street address

Shahid Rajaee Avenue, Kashan

City

Kashan

Province

Isfehan

Postal code

1771844351

Phone

+98 31 5546 3378

Email

asemi_z@kaums.ac.ir

1

Sponsor: Name of organization / entity

Vice chancellor for research, Arak University of Medical Sciences

Full name of responsible person

Mohammad Rafiee

Street address

Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak

City

Arak

Province

Markazi

Postal code

3814113634

Phone

+98 86 3223 3823

Email

rafiee-m@aums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: No
Title of funding source: Vice chancellor for research, Arak University of Medical Sciences
Proportion provided by this source: 50
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

2

Sponsor: Name of organization / entity

Vice chancellor for research, Kashan University of Medical Sciences

Full name of responsible person

Gholamali Hamidi

Street address

Ghotbe Ravandi Boulevard, Kashan

City

Kashan

Province

Isfehan

Postal code

1771844351

Phone

+98 31 5546 3378

Email

Gholamali_h@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: No
Title of funding source: Vice chancellor for research, Kashan University of Medical Sciences
Proportion provided by this source: 50
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

Zatollah Asemi

Full name of responsible person

Kashan University of Medical Sciences

Position

Associate professor

Latest degree

Ph.D.

Other areas of specialty/work

Nutrition

Street address

Ghotbe Ravandi Boulevard, Kashan

City

Kashan

Province

Isfehan

Postal code

1771844351

Phone

+98 31 5546 3378

Email

asemi_z@kaums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Kashan University of Medical Sciences

Full name of responsible person

Zatollah Asemi

Position

Nutrition PhD

Latest degree

Ph.D.

Other areas of specialty/work

Nutrition

Street address

Ghotbe Ravandi Boulevard, Kashan

City

Kashan

Province

Isfehan

Postal code

1771844351

Phone

+98 36 1446 3378

Fax

+98 31 5546 3378

Email

asemi_r@yahoo.com

Web page address

Person responsible for updating data

Contact: Name of organization / entity

Kashan University of Medical Sciences

Full name of responsible person

Zatollah Asemi

Position

Nutrition PhD

Latest degree

Ph.D.

Other areas of specialty/work

Nutrition

Street address

Ghotbe Ravandi Boulevard, Kashan

City

Kashan

Province

Isfehan

Postal code

1771844351

Phone

+98 31 5546 3378

Fax

Email

asemi_r@yahoo.com

Web page address

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
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available

Effects of folic acid supplementation on insulin resistance and inflammatory factor in overweight women with polycystic ovary syndrome