Effect of supplementation in treatment of patients with gestational diabetes

Clinical trial of the effect of combined omega-3 fatty acids and vitamin D supplementation compared with the placebo on metabolic profiles and pregnancy outcomes in patients with gestational diabetes

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201701305623N106

Enrollment

120

Registered

2017-02-09

Start date

2016-09-08

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 2000 mg omega-3 fatty acids daily (Zahravi, Tabriz, Iran) and 50000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), for 6 weeks orally. Intervention 2:

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Patients with gestational diabetes Age range of 18 to 40 years

Exclusion criteria

Exclusion criteria: Taking omega-3 fatty acids supplements Insulin therapy Placenta abruption Pre-eclampsia Eclampsia Hypo and hyperthyroidism Smokers

Design outcomes

Primary

Measure	Time frame
Hs-CRP. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.	—

Secondary

Measure	Time frame
Total antioxidant. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Newborns' weight. Timepoint: The first 24 h after birth. Method of measurement: Scale.;Newborn length. Timepoint: The first 24 h after birth. Method of measurement: Girth measuring tape.;Polyhydramnios. Timepoint: After the intervention. Method of measurement: Sonography.;Apgar score. Timepoint: Delivery time. Method of measurement: Clinical observation.;Newborn's bilirubin. Timepoint: Delivery time. Method of measurement: Enzymatic kit.;Newborns' hospitalization. Timepoint: After delivery. Method of measurement: Medical record.;Maternal pre-eclampsia. Timepoint: After delivery. Method of measurement: Medical record.	—

Measure

Time frame

Total antioxidant. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Newborns' weight. Timepoint: The first 24 h after birth. Method of measurement: Scale.;Newborn length. Timepoint: The first 24 h after birth. Method of measurement: Girth measuring tape.;Polyhydramnios. Timepoint: After the intervention. Method of measurement: Sonography.;Apgar score. Timepoint: Delivery time. Method of measurement: Clinical observation.;Newborn's bilirubin. Timepoint: Delivery time. Method of measurement: Enzymatic kit.;Newborns' hospitalization. Timepoint: After delivery. Method of measurement: Medical record.;Maternal pre-eclampsia. Timepoint: After delivery. Method of measurement: Medical record.

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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