effect of Supplementation in combination with diet therapy in treatment of polycystic ovary syndrome

The effect of vitamin D supplementation on anthropometric indices and androgen hormones in women with polycystic ovary syndrome treated with low calorie diet

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016062710826N19

Enrollment

Registered

2016-12-08

Start date

2016-09-22

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. Sclerocystic ovary syndrome? Stein-Leventhal syndrome

Interventions

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

Treatment - Other

Placebo

Intervention group: Vitamin D supplements, 50000 IU, weekly, for 12 weeks orally.

Control group: Placebo,weekly for 12 weeks orally

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: aged 18-40 years old, Patients with PCOS according to Rotterdam criteria, BMI between 25 to 40, Serum vitamin D levels less than 20 ng /ml, not using weight loss diet and vitamin D supplement Over the last 3 months, not using hormone therapy, not using certain drugs including Weight loss drugs and multivitamin supplements mineral, not smoking, not doing heavy and professional exercise. Exclusion criteria: individuals with diabetes, Cardiovascular disease, Liver, kidney, thyroid and para- thyroid, Cushing's syndrome, osteomalacia, changes in physical activity, Non-compliance with diet and supplementation

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
?DHEA ( Dehydroepiandrosterone sulfate). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Elisa method.;Total testosterone. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Elisa method.;SHBG (sex hormone-binding globulin ). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Elisa method.;Percent of body fat, percent of free fat mass. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Body composition device.	—

Measure

Time frame

?DHEA ( Dehydroepiandrosterone sulfate). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Elisa method.;Total testosterone. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Elisa method.;SHBG (sex hormone-binding globulin ). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Elisa method.;Percent of body fat, percent of free fat mass. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Body composition device.

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Secondary

Measure	Time frame
Free androgen index. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Total testosterone/ SHBG.;Weight. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: OMRON scale with an accuracy of 0.1kg.;Body Mass Index. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: weight/ height*height.;Waist circumference. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: By meter in cm.;Hip circumference. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: By meter in cm.;25OHD (25-hydroxy vitamin D). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Elisa method.	—

Measure

Time frame

Free androgen index. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Total testosterone/ SHBG.;Weight. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: OMRON scale with an accuracy of 0.1kg.;Body Mass Index. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: weight/ height*height.;Waist circumference. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: By meter in cm.;Hip circumference. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: By meter in cm.;25OHD (25-hydroxy vitamin D). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Elisa method.

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Countries

Iran (Islamic Republic of)

Contacts

Public Contactsamira jafari sfidvajani

Shahid Sadoughi University of Medical Sciences

samira.jafari67@gmail.com+98 25 3292 5181

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 8, 2026