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Effect of the Folic Acid and Vitamin B12 Supplements with Metformin on the Plasma Homocysteine Levels in Women with Polycystic Ovary Syndrome

Protocol summary

Summary
Polycystic ovary syndrome (PCOs) is a common endocrine disorder in the reproductive age. It involves hyperandrogenism, ovulatory disturbances, infertility, obesity, hyperinsulinemia, insulin resistance and cardiovascular diseases (CVD). Metformin is one of the most common prescribed oral drugs for patients with PCOs that sensitize body to insulin. Moreover, Metformin induces increase in homocysteine (Hcy) levels, as an independent risk factor for CVD, by reducing of the plasma vitamin B12 or folate levels. This study is designed to examine the effects of metformin therapy and the folic acid and vitamin B12 supplements on the serum Hcy levels and other cardiovascular factors such as lipid profile and insulin resistance, in patients with PCOs. A total of 150 PCOs patients are selected by using Rotterdam criteria for PCOs (2003) and inclusion and exclusion criteria. Subjects are randomly divided to three groups. The first group receives metformin; the second group receives metformin with vitamin B12 supplement; the third group receives metformin with folic acid supplement, each for 6 months. Process including: Collection of the blood samples (12 h fasting state), measurement of the serum Hcy levels, vitamin B12 and folic acid levels, before and after treatment. Measurement of lipid profile [total cholesterol, HDL-C, LDL-C and triglyceride (TG)], Hormonal parameters [FSH, LH, total testosterone, free testosterone, dehydroepiandrosterone sulphate (DHEAS), 17-OH-progesterone and prolactin], fasting plasma insulin levels, fasting plasma glucose levels and insulin resistance (according to QUICKI and HOMA).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201108171760N14
Registration date: 2012-07-14, 1391/04/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-07-14, 1391/04/24
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and technology, Babol University of Medical Sciences
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of the Folic Acid and Vitamin B12 Supplements with Metformin on the Plasma Homocysteine Levels in Women with Polycystic Ovary Syndrome
Public title
Effect of the Folic Acid and Vitamin B12 Supplements with Metformin on the Plasma Homocysteine Levels in Women with Polycystic Ovary Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with PCOs aged 17-35 years. Exclusion criteria: Patients with each background of malady (such as, cardiovascular diseases, diabetes, congenital adrenal hyperplasia,…); using of drugs anti-pregnancy, hormonal, anti-overweight and medications known to interfere with folic acid and vitamin B12 metabolism (such as, metotreksat, nitric oxide and Azaribine), history of hypertension, high activity of body, alcoholic, smoker and subjects with > 120 mg/ml serum folic acid and ≥1000 pg/ml vitamin B12 than normal ranges.
Age
From 17 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical sciences, Ganjafroz Avenue
City
Babol
Postal code
Approval date
2011-08-13, 1390/05/22
Ethics committee reference number
4419/30/ژ/پ

Health conditions studied

1

Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
hyperhomocysteinaemia
Timepoint
During the period of six months after treatment
Method of measurement
clinical and laboratory findings

2

Description
hyperinsulinaemia
Timepoint
During the period of six months after treatment
Method of measurement
clinical and laboratory findings

Secondary outcomes

1

Description
serum folic acid levels
Timepoint
Six months after starting treatment.
Method of measurement
laboratory findings

2

Description
serum vitamin B12 levels
Timepoint
Six months after starting treatment.
Method of measurement
laboratory findings

3

Description
serum homocysteine(HCY) ​​levels
Timepoint
Six months after starting treatment.
Method of measurement
laboratory findings

Intervention groups

1

Description
Control group(1): Treated with metformin tablets (500 mg twice daily).Treated for 6 months.
Category
Treatment - Drugs

2

Description
Intervention: group(2):Treated with metformin tablets (500 mg twice daily) with supplements of vitamin B12 (1000 micrograms weekly injections), will be treated for 6 months.
Category
Treatment - Drugs

3

Description
Intervention: group(3):Treated with metformin tablets (500 mg twice daily) with folic acid supplements (1 mg daily), will be treated for 6 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemehzahra Fertility & infertility hospital
Full name of responsible person
Maryam GHolinejad Chari
Street address
Fatemehzahra Fertility & reproductive Health Research Center, Noshirvani street
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Vice Chancellor for Research and Technology, Babol University of Medical Sciences, Ganjafroz Avenue
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Babol 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
Name of organization / entity
Fatemehzahra Fertility & reproductive Health Research Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/responsible of Reseach Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Research Center - noshirvani street
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
Email
ngh_pa@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Fatemehzahra Fertility & reproductive Health Research Center
Full name of responsible person
Seddigheh Esmaeilzadeh
Position
Gynecologist
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Research, Noshirvani street
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
Email
sesmael@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Fatemehzahra Fertility & reproductive Health Research Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/responsible of Reseach Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Research Center - noshirvani street
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
Email
ngh_pa@yahoo.com
Web page address

Sharing plan

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