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 in patients with gestational diabetes

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201605135623N78

Enrollment

140

Registered

2016-05-21

Start date

2016-03-06

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: Control group: Placebo (Zahravi, Tabriz, Iran), for 6 weeks orally. Intervention 2: Intervention group 1: Combined 1000 mg omega-3 fatty acids twice a day (Zahravi, Tabriz, Iran) and 5

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Patients with gestational diabetes in the age range of 18 to 40 years

Exclusion criteria

Exclusion criteria: Taking vitamin D and/or omega-3 fatty acids supplements Taking insulin Placenta abruption Preeclampsia Eclampsia Hypo and hyperthyroidism Smokers Kidney or liver diseases

Design outcomes

Primary

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

Secondary

Measure	Time frame
Triglycerides. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;HDL-cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;LDL. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;VLDL. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;FPG. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.	—

Measure

Time frame

Triglycerides. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;HDL-cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;LDL. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;VLDL. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;FPG. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_r@yahoo.com+98 31 5546 3378

Outcome results

None listed

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