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Effects of folic acid supplementation on nitric oxide, factors of lipid peroxidation and biomarkers of oxidative stress in overweight and obese women with polycystic ovary syndrome

Protocol summary

Summary
Objective: The aim of this study is to determine the effects of folic acid supplementation on nitric oxide, factors of lipid peroxidation and biomarkers of oxidative stress in overweight women with polycystic ovary syndrome (PCOS). Study design: parallel double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Women aged 18-35 years with overweight diagnosed with PCOS will be included in this study. Individuals with neoplastic, cardiovascular disorders, malabsorptive disorders, current or previous (within the last 6 months) use of hormonal, antidiabetic medications and anti-obesity medications will be excluded in the study. Population and sample size: 75 women with PCOS eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either 1 mg folic acid supplement (intervention group: n=25), 5 mg folic acid supplement (intervention group: n=25) or placebo (control group: n=25). Fasting blood samples will be taken at baseline and after 8-wk intervention to measure metabolic profiles and inflammatory factor. Start and End Date of Intervention: 8 weeks (November 20, 2013-Jonvier 20, 2014). Outcomes: Baseline and End-of-trial nitric oxide (NO), Malondialdehyde (MDA), total antioxidant capacity (TAC) and glutathione (GSH) levels.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201311205623N12
Registration date: 2013-12-01, 1392/09/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-12-01, 1392/09/10
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
Kashan University of Medical Sciences
Expected recruitment start date
2013-11-20, 1392/08/29
Expected recruitment end date
2014-01-19, 1392/10/29
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Effects of folic acid supplementation on nitric oxide, factors of lipid peroxidation and biomarkers of oxidative stress in overweight and obese 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 18-35 years; diagnosed with PCOS. Exclusion Criteria: Individuals with neoplastic; cardiovascular disorders; malabsorptive disorders; current or previous (within the last 6 months) use of hormonal; antidiabetic medications; anti-obesity medications.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Postal code
Approval date
2013-11-20, 1392/08/29
Ethics committee reference number
3461/1/5/29/P

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
Nitric oxide
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

2

Description
Malondialdehyde
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

3

Description
Total Antioxidant Capacity
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

4

Description
Total glutathione
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

5

Description
Catalase
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

Secondary outcomes

empty

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
Naghavi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact

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
Other areas of specialty/work
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Postal code
Phone
+98 36 1446 3378
Fax
Email
asemi_z@kaums.ac.irasemi_r@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Zatollah Asemi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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