Effect of supplementation in treatment of patients with endometrial hyperplasia

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201704155623N107

Enrollment

Registered

2017-05-12

Start date

2016-04-20

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

Endometrial hyperplasia. Endometrial hyperplasia

Interventions

Intervention 1: Intervention group: 5 mg folate (Tehran Darou, Tehran, Iran), daily, for 12 weeks orally. Intervention 2: Control group: Placebo (Barij Essence, Kashan, Iran), daily, for 12 weeks oral

Treatment - Drugs

Intervention group: 5 mg folate (Tehran Darou, Tehran, Iran), daily, for 12 weeks orally.

Control group: Placebo (Barij Essence, Kashan, Iran), daily, for 12 weeks orally.

Eligibility

Sex/Gender

Female

Age

30 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients with endometrial hyperplasia; aged 30 to 50 years. Exclusion criteria: Unwillingness to cooperate.

Exclusion criteria

Exclusion criteria:

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: Biopsy.	—

Secondary

Measure	Time frame
Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.	—

Measure

Time frame

Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Fasting plasma glucose. 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; asemi_r@yahoo.com+98 31 5546 3378

Outcome results

None listed

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