Effect of supplementation in treatment of patients with endometrial hyperplasia

Clinical trial of the effect of vitamin D supplementation compared with the placebo on treatment and metabolic profiles in patients with endometrial hyperplasia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201606275623N86

Enrollment

Registered

2016-07-01

Start date

2016-05-25

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

Endometrial hyperplasia. Endometrial hyperplasia

Interventions

Intervention 1: Intervention group: 50000 IU vitamin D (Zahravi, Tabriz, Iran), once a week, for 12 weeks orally. Intervention 2: Control group: Placebo (Barij Essence, Kashan, Iran), once a week, for

Eligibility

Sex/Gender

Female

Age

35 Years to 55 Years

Inclusion criteria

Inclusion criteria: Aged 35 to 55 years Patients with endometrial hyperplasia informed consent

Exclusion criteria

Exclusion criteria: Menopausal women History of cardiovascular disease Diabetes mellitus Fasting plasma glucose (FPG) > 126 mg/dL Consumption of antihyperglycemic agents including metformin Triglycerides levels > 500 mg/dL Systolic blood pressure = 160 mmHg Diastolic blood pressure = 110 mmHg Untreated thyroid disease

Design outcomes

Primary

Measure	Time frame
Response to treatment. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Sonography.	—

Secondary

Measure	Time frame
Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;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.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. 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.;Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Using HOMA formula.;VLDL cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.	—

Measure

Time frame

Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;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.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. 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.;Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Using HOMA formula.;VLDL cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.

—

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