Effect of combined vitamin E and zinc supplementation in treatment of gestational diabetes mellitus

Clinical trial of the effect of combined vitamin E and zinc supplementation compared with the placebo on metabolic profiles and gene expression related to insulin and lipid in women with gestational diabetes mellitus

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170513033941N26

Enrollment

Registered

2018-01-07

Start date

2017-11-27

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

Gestational diabetes mellitus. Unspecified diabetes mellitus in pregnancy, childbirth and the puerperium

Interventions

Intervention 1: Intervention group: 400 IU vitamin E (Zahravi, Tabriz, Iran) and 30 mg elemental zinc (Donyaye Behdasht, Tehran, Iran) daily for 6 weeks orally. Intervention 2: Control group: Placebo

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients with gestational diabetes mellitus. Individuals aged 18 to 40 years.

Exclusion criteria

Exclusion criteria: Exclusion criteria: Taking zinc and vitamin E supplements 3 months before the intervention Insulin therapy required during the intervention Pre-eclampsia Eclampsia Hypo and hyperthyroidism

Design outcomes

Primary

Measure	Time frame
Insulin. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Elisa kit.;Insulin resistance. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Calculation using HOMA formula.	—

Secondary

Measure	Time frame
Total cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;Expressed levels of PPAR-? gene. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: PCR.;LDL-cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;VLDL-cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;Expressed levels of LDLR gene. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: PCR.	—

Measure

Time frame

Total cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;Expressed levels of PPAR-? gene. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: PCR.;LDL-cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;VLDL-cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;Expressed levels of LDLR gene. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: PCR.

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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