Antioxidants in Gestational Diabetes

Phase 4

Completed

• Conditions: Gestational Diabetes Mellitus
• Interventions: Drug: L-ascorbic acid

• Registration Number: NCT02355197
• Lead Sponsor: Cairo University

Brief Summary

Fasting and two hours postprandial blood sugar were done to all cases between 28 and 32 weeks and high blood sugar levels were found so Cases were controlled by both diet and insulin.

The 200 pregnant women with Gestational diabetes mellitus were randomized using automated web based randomization system into 2 groups, Group1 received 1 gram L-ascorbic acid (vitamin C )per day from the time of diagnosis until the time of delivery in addition to routine treatment of diabetes (diet \& insulin). Group2 received only the treatment of diabetes

Detailed Description

The 200 pregnant women with Gestational diabetes mellitus were randomized using automated web based randomization system into 2 groups, Group1 received 1 gram L-ascorbic acid oral once daily (vitamin C )per day from the time of diagnosis until the time of delivery in addition to routine treatment of diabetes (diet \& insulin). Group2 received only the treatment of diabetes (diet and insulin

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2015-01-26
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Study First Submitted QC: 2015-02-03
• Study First Posted: 2015-02-04
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Women with the diagnosis of GDM

Exclusion Criteria

• Women with multiple pregnancies
• Chronic medical disorders e.g. anemia
• Hypertension
• Liver disease or renal disease
• Those with obstetric problems other than GDM (e.g. pre-eclampsia & antepartum hemorrhage) or smokers and women with preexisting type I or II diabetes mellitus were excluded from our study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
antioxidant	L-ascorbic acid	1 gram L-ascorbic acid (vitamin C capsule) orally once per day from the time of diagnosis until the time of delivery in addition to treatment for gestational diabetes mellitus in the form of diet and insulin

Primary Outcome Measures

Name	Time	Method
neonatal outcome assessed by neonatal ICU admission	1 week after delivery

Secondary Outcome Measures

Name	Time	Method
oxidative stress parameters: non enzymatic and enzymatic oxidative stress parameters in maternal blood plasma/lysate in women with GDM named glutathione,superoxide dismutase ,catalase and glutathione peroxidase	9 months of pregnancy
oxidative stress parameters: non enzymatic and enzymatic oxidative stress parameters in neonatal blood in women with GDM named malondialdahyde and superoxide dismutase	9 months of pregnancy
oxidative stress parameters: non enzymatic and enzymatic oxidative stress parameters in placental tissue homogenates in women with GDM named glutathione ,malondialdahyde,superoxide dismutase ,catalase and glutathione peroxidase	9 months of pregnancy

Trial Locations

Locations (1)

Kasr Alainy medical school; 🇪🇬 Cairo, Egypt