Antioxidants in Gestational Diabetes

NCT ID: NCT02355197

Last Updated: 2017-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-02-28

Brief Summary

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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

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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

Conditions

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Gestational Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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antioxidant

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

Group Type ACTIVE_COMPARATOR

L-ascorbic acid

Intervention Type DRUG

1 gram L-ascorbic acid (vitamin C …..) per day from the time of diagnosis until the time of delivery

control

Only treatment for gestational diabetes mellitus in the form of diet and insulin

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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L-ascorbic acid

1 gram L-ascorbic acid (vitamin C …..) per day from the time of diagnosis until the time of delivery

Intervention Type DRUG

Other Intervention Names

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vitamin C

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Maged

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Maged

Role: PRINCIPAL_INVESTIGATOR

Kasr Alainy medical school

Locations

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Kasr Alainy medical school

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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124

Identifier Type: -

Identifier Source: org_study_id

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