The effect of folic acid on complications of endometrial hyperplasia patients

The effects of folic acid supplementation on lipid profile and oxidative stress parameters in endometrial hyperplasia patients in comparison with placebo: a randomized double-blinded controlled clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016060122562N2

Enrollment

Registered

2016-06-10

Start date

2016-06-21

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: received one capsule of 5mg folic acid, daily for three months. Intervention 2: control: received one capsule of placebo daily for three months.

Eligibility

Sex/Gender

Female

Age

35 Years to 55 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Smoking Unwilling to cooperate Menopausal women History of cardiovascular disease Diabetes mellitus Hypertension Untreated thyroid disease

Design outcomes

Primary

Measure	Time frame
Regression. Timepoint: Before and three months after intervention. Method of measurement: Sonography.	—

Secondary

Measure	Time frame
Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Serum insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;HOMA-IR. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.;QUICKI. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;VLDL-cholesterol. 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.;LDL-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: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. 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.;Total homocysteine. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzyma	—

Measure

Time frame

Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Serum insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;HOMA-IR. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.;QUICKI. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;VLDL-cholesterol. 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.;LDL-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: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. 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.;Total homocysteine. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzyma

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Fereshteh Bahmani

Kashan University of Medical Sciences

bahmani@kaums.ac.ir+98 315554002100

Outcome results

None listed

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