NCT01762826

Brief Summary

Comparison of different inositol stereoisomears in preventing adverse obstetric outcomes in non-obese pregnant women at high risk for gestational diabetes mellitus.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2012

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 8, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 8, 2013

Status Verified

September 1, 2012

Enrollment Period

7 months

First QC Date

November 25, 2012

Last Update Submit

January 4, 2013

Conditions

GDM

Keywords

InositolGDM

Outcome Measures

Primary Outcomes (1)

  • OGTT result

    OGTT is the mainstay of obstetric outcomes in GDM

    24-28 weeks' gestation

Secondary Outcomes (3)

  • Fetal measurements at third trimester

    28 weeks

  • Delivery data

    25-42 weeks gestations'

  • Adverse obstetric outcome

    from first elevated oral fasting glucose (above 92 mg%) till the end/termination of pregnancy (latter 42 weeks gestation)

Study Arms (4)

Placebo control

Diet pills of 400 mcg of acid folic daily

Dietary Supplement: Placebo

D-chiro-inositol / Myo-inositol

Diet sachets 2000 mg myo-inositol and 250 mg d-chiro-inositol and 400 mcg folic acid daily

Dietary Supplement: D-Chiro / Myo-inositol

D-chiro-inositol

Diet pills with 500 mg d-chiro-inositol and 400 mcg folic acid daily

Dietary Supplement: D-chiro-inositol

Myo-inositol

Diet sachets with 2000 mg myo-inositol and 200 mcg folic acid twice daily

Dietary Supplement: Myo-inositol

Interventions

Myo-inositolDIETARY_SUPPLEMENT

Dietary control plus Myo-inositol

Also known as: Supplementation of myo-inositol plus dietary control
Myo-inositol
D-chiro-inositolDIETARY_SUPPLEMENT

Dietary control plus D-Chiro-Inositol supplementation

D-chiro-inositol
D-Chiro / Myo-inositolDIETARY_SUPPLEMENT

Dietary control Supplementation with myo and d-chiro inositol

D-chiro-inositol / Myo-inositol
PlaceboDIETARY_SUPPLEMENT

Dietary control plus folic acid 400 mcg daily

Placebo control

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Non obese pregnant women during first trimester of pregnancy with scared fasting glucose (above 92 mg%)

You may qualify if:

  • pregnancy below 20 weeks gestation BMI below 30 Fasting glucose between 92 and 126 mg% Singleton pregnancy Naturally conceived

You may not qualify if:

  • obese patient Fasti g glucose above 126 or below 92

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Inositol

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Claudio Celentano, MD

    ObGyn Dept University of Chieti

    STUDY DIRECTOR

  • Barbara Matarrelli, MD

    ObGyn Dept Univ of Chieti

    PRINCIPAL INVESTIGATOR

  • Ester Vitacolonna, MD

    Diabetology Dept Univ of Chieti

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 25, 2012

First Posted

January 8, 2013

Study Start

September 1, 2012

Primary Completion

April 1, 2013

Study Completion

September 1, 2013

Last Updated

January 8, 2013

Record last verified: 2012-09