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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201108171760N14
Enrollment
150
Registered
2012-07-14
Start date
2011-08-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovary syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: Control group(1): Treated with metformin tablets (500 mg twice daily).Treated for 6 months. Intervention 2: Intervention: group(2):Treated with metformin tablets (500 mg twice dail
Treatment - Drugs
Control group(1): Treated with metformin tablets (500 mg twice daily).Treated for 6 months.
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.
Intervention: group(3):Treated with metformin tablets (500 mg twice daily) with folic acid supplements (1 mg daily), will be treated for 6 months.

Sponsors

Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
17 Years to 35 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Hyperhomocysteinaemia. Timepoint: During the period of six months after treatment. Method of measurement: clinical and laboratory findings.;Hyperinsulinaemia. Timepoint: During the period of six months after treatment. Method of measurement: clinical and laboratory findings.

Secondary

MeasureTime frame
Serum folic acid levels. Timepoint: Six months after starting treatment. Method of measurement: laboratory findings.;Serum vitamin B12 levels. Timepoint: Six months after starting treatment. Method of measurement: laboratory findings.;Serum homocysteine(HCY) ??levels. Timepoint: Six months after starting treatment. Method of measurement: laboratory findings.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNargess Gholizadeh Pasha

Fatemehzahra Fertility & reproductive Health Research Center

ngh_pa@yahoo.com+98 11 1227 4881

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026