Effect of supplementation in treatment of women with gestational diabetes

Clinical trial of the effect of combined probiotic and vitamin D supplementation compared with the placebo on metabolic profiles in women with gestational diabetes

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201706075623N119

Enrollment

Registered

2017-06-09

Start date

2017-05-16

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. Diabetes mellitus in pregnancy, unspecified

Interventions

Intervention 1: Intervention group: Probiotic supplements (Zist Takhmir, Tehran, Iran), 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Patients with gestational diabetes Aged 18 to 40 years

Exclusion criteria

Exclusion criteria: Pre-eclampsia Eclampsia Hypo and hyperthyroidism Smokers Taking vitamin D, probiotic and/or symbiotic supplements during the last 3 months prior to the intervention Insulin therapy during the intervention

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: 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.;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 antioxidant capacity. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Total glutathione. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;VLDL. 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.;Hs-CRP. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Elisa kit.;Malondialdehyde. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Nitric oxide. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Fasting plasma glucose. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;Newborn's head circumference. Timepoint: Delivery time. Method of measurement: Tape.;Polyhydramnios. Timepoint: End-of-trial. Method of measurement: Sonographic.;Newborn's bilirubin. Timepoint: Delivery time. Method of measurement: Enzymatic kit.;Apgar score. Timepoint: Delivery time. Method of measurement: Clinical observation.;Newborns' hypoglycemia. Timepoint: After delivery. Method of measurement: Enzymatic kit.;Preterm delivery. Timepoint: After delivery. Method of measurement: Medical record.;Maternal pre-eclampsia. Timepoint: After delivery. Method	—

Measure

Time frame

Total cholesterol. 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.;HDL-cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Total glutathione. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;VLDL. 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.;Hs-CRP. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Elisa kit.;Malondialdehyde. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Nitric oxide. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Fasting plasma glucose. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;Newborn's head circumference. Timepoint: Delivery time. Method of measurement: Tape.;Polyhydramnios. Timepoint: End-of-trial. Method of measurement: Sonographic.;Newborn's bilirubin. Timepoint: Delivery time. Method of measurement: Enzymatic kit.;Apgar score. Timepoint: Delivery time. Method of measurement: Clinical observation.;Newborns' hypoglycemia. Timepoint: After delivery. Method of measurement: Enzymatic kit.;Preterm delivery. Timepoint: After delivery. Method of measurement: Medical record.;Maternal pre-eclampsia. Timepoint: After delivery. Method

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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: Mar 5, 2026