Effect of supplementation in treatment of women with polycystic ovary syndrome

Clinical trial of the effect of 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

IRCT201606115623N82

Enrollment

Registered

2016-07-01

Start date

2016-04-24

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 ovarian syndrome

Interventions

Intervention 1: Intervention group: Vitamin D supplements, 50000 IU, every two weeks, for 12 weeks orally. Intervention 2: Control group: Placebo capsule, every two weeks for 12 weeks orally.

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Patients with phenotype B of PCOS according to Rotterdam criteria Aged between18 to 40 years old

Exclusion criteria

Exclusion criteria: Pregnant women Women with endocrine diseases including diabetes or impaired glucose tolerance

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: Questionnaire.;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.;Free testosterone. 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: Questionnaire.;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.;Free testosterone. 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
Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Hs-CRP. 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.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;VLDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Hirsutism. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Clinical observation.	—

Measure

Time frame

Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Hs-CRP. 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.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;VLDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;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