Back to resultsAntioxidants in Gestational Diabetes
Primary Purpose
Gestational Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
L-ascorbic acid
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Diabetes Mellitus focused on measuring antioxidants, Gestational diabetes mellitus, oxidative stress
Eligibility Criteria
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
Sites / Locations
- Kasr Alainy medical school
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
antioxidant
control
Arm Description
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
Only treatment for gestational diabetes mellitus in the form of diet and insulin
Outcomes
Primary Outcome Measures
neonatal outcome assessed by neonatal ICU admission
Secondary Outcome Measures
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
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
oxidative stress parameters: non enzymatic and enzymatic oxidative stress parameters in neonatal blood in women with GDM named malondialdahyde and superoxide dismutase
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02355197
Brief Title
Antioxidants in Gestational Diabetes
Official Title
Physiological Effects of Gestational Diabetes on the Placenta and Neonatal Outcome; Role of Antioxidant Administration
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus
Keywords
antioxidants, Gestational diabetes mellitus, oxidative stress
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
antioxidant
Arm Type
Active Comparator
Arm Description
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
Arm Title
control
Arm Type
No Intervention
Arm Description
Only treatment for gestational diabetes mellitus in the form of diet and insulin
Intervention Type
Drug
Intervention Name(s)
L-ascorbic acid
Other Intervention Name(s)
vitamin C
Intervention Description
1 gram L-ascorbic acid (vitamin C …..) per day from the time of diagnosis until the time of delivery
Primary Outcome Measure Information:
Title
neonatal outcome assessed by neonatal ICU admission
Time Frame
1 week after delivery
Secondary Outcome Measure Information:
Title
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
Time Frame
9 months of pregnancy
Title
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
Time Frame
9 months of pregnancy
Title
oxidative stress parameters: non enzymatic and enzymatic oxidative stress parameters in neonatal blood in women with GDM named malondialdahyde and superoxide dismutase
Time Frame
9 months of pregnancy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged
Organizational Affiliation
Kasr Alainy medical school
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12151
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Antioxidants in Gestational Diabetes
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