Effect of supplementation in treatment of women with polycystic ovary syndrome

Clinical trial of the effect of multi mineral-vitamin D supplementation compared with the placebo on metabolic profiles in women with polycystic ovary syndrome

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201701165623N103

Enrollment

Registered

2017-01-22

Start date

2017-01-12

Completion date

Unknown

Last updated

2019-11-05

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

Conditions

Polycystic ovary syndrome. Polycystic ovary syndrome

Interventions

Intervention 1: Intervention group: Multi mineral-vitamin D supplements (Vitane, Wolfratshausen, Germany), 400 mg calcium, 100 mg magnesium, 4 mg zinc, 200 IU vitamin D3, daily, for 12 weeks orally. I

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Patients with PCOS according to Rotterdam criteria Aged 18 to 40 years

Exclusion criteria

Exclusion criteria: Intake of magnesium, zinc, calcium and/or vitamin D supplementswithin the past 3 months. Pregnant women Metabolic disorders, including hyperandrogenism, Cushing’s syndrome, androgen secreting tumors, hyperprolactinemia. Thyroid dysfunction Not residing in Arak area

Design outcomes

Primary

Measure	Time frame
Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.;Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total testosterone. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;SHBG. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.	—

Measure

Time frame

Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.;Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total testosterone. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;SHBG. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.

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Secondary

Measure	Time frame
Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;VLDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;LDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Hirsutism. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Clinical observation.	—

Measure

Time frame

Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;VLDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;LDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Hirsutism. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Clinical observation.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_z@kaums.ac.ir+98 31 5546 3378

Outcome results

None listed

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