NCT02355197

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2015

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
Last Updated

March 24, 2017

Status Verified

March 1, 2017

Enrollment Period

2.1 years

First QC Date

January 26, 2015

Last Update Submit

March 22, 2017

Conditions

Gestational Diabetes Mellitus

Keywords

antioxidantsGestational diabetes mellitusoxidative stress

Outcome Measures

Primary Outcomes (1)

  • neonatal outcome assessed by neonatal ICU admission

    1 week after delivery

Secondary Outcomes (3)

  • 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

  • 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

Study Arms (2)

antioxidant

ACTIVE COMPARATOR

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

Drug: L-ascorbic acid

control

NO INTERVENTION

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

Interventions

L-ascorbic acidDRUG

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

Also known as: vitamin C
antioxidant

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women with the diagnosis of GDM

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, Cairo Governorate, 12151, Egypt

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Ahmed Maged

    Kasr Alainy medical school

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 26, 2015

First Posted

February 4, 2015

Study Start

January 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 24, 2017

Record last verified: 2017-03

Locations

EG(1)