Effect of supplementation in treatment of gestational diabetes

Clinical trial of the effect of combined omega-3 and vitamin E supplementation on pregnancy outcomes in gestational diabetes

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201507035623N47

Enrollment

Registered

2015-07-19

Start date

2015-06-09

Completion date

Unknown

Last updated

2019-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational diabetes. Diabetes mellitus in pregnancy, unspecified

Interventions

Intervention 1: Intervention group: Combined omega-3 and vitamin E pearl, 1000 mg omega-3 and 400 IU vitamin E, daily, for 6 weeks orally. Intervention 2: Control group: Placebo pearl, daily, for 6 we

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Pregnant women aged 18-40 years Diagnosed with GDM at 24-28 week gestation

Exclusion criteria

Exclusion criteria: Placenta abruption Preeclampsia Eclampsia Hypo- and hyperthyroidism Urinary tract infection Smokers Kidney or liver diseases

Design outcomes

Primary

Measure	Time frame
Total antioxidant capacity. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.;Hs-CRP. Timepoint: Baseline and End-of-trial. Method of measurement: Elisa.;Nitric oxide. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.	—

Measure

Time frame

Total antioxidant capacity. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.;Hs-CRP. Timepoint: Baseline and End-of-trial. Method of measurement: Elisa.;Nitric oxide. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.

—

Secondary

Measure	Time frame
Newborn length. Timepoint: The first 24 h after birth. Method of measurement: Scale.;Newborns' weight. Timepoint: The first 24 h after birth. Method of measurement: Scale.;Polyhydramnios. Timepoint: After the intervention. Method of measurement: Sonography.;Newborn's head circumference. Timepoint: Delivery time. Method of measurement: Tape.;Newborn's bilirubin. Timepoint: Delivery time. Method of measurement: Enzymatic kit.;Apgar score. Timepoint: Delivery time. Method of measurement: Clinical observation.;Preterm delivery. Timepoint: After delivery. Method of measurement: Medical record.;Maternal pre-eclampsia. Timepoint: After delivery. Method of measurement: Medical record.;Maternal hospitalization. Timepoint: After delivery. Method of measurement: Medical record.;Newborns' hospitalization. Timepoint: After delivery. Method of measurement: Medical record.	—

Measure

Time frame

Newborn length. Timepoint: The first 24 h after birth. Method of measurement: Scale.;Newborns' weight. Timepoint: The first 24 h after birth. Method of measurement: Scale.;Polyhydramnios. Timepoint: After the intervention. Method of measurement: Sonography.;Newborn's head circumference. Timepoint: Delivery time. Method of measurement: Tape.;Newborn's bilirubin. Timepoint: Delivery time. Method of measurement: Enzymatic kit.;Apgar score. Timepoint: Delivery time. Method of measurement: Clinical observation.;Preterm delivery. Timepoint: After delivery. Method of measurement: Medical record.;Maternal pre-eclampsia. Timepoint: After delivery. Method of measurement: Medical record.;Maternal hospitalization. Timepoint: After delivery. Method of measurement: Medical record.;Newborns' hospitalization. Timepoint: After delivery. Method of measurement: Medical record.

—

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