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Myo-inositol in Obese Pregnant Women

NCT01047982 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2014-02-28

No results posted yet for this study

Summary

Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. This is a prospective, randomized, double center, placebo-controlled study. Two hundred and twenty obese pregnant women will be included in the trial and, after an informed consent, will assume randomly 2 g of myo-inositol twice a day or placebo from 12-13th weeks gestation until delivery. Then,they will perform an Oral Glucose Tolerance Test (OGTT) at 24-28th weeks gestation. Records about delivery (gestational age, neonatal weight...) will be registered.

Conditions

  • Gestational Diabetes

Interventions

DIETARY_SUPPLEMENT

myo-inositol

myo-inositol 2 grams plus folic acid 400 mcg twice a day

OTHER

folic acid 400 mcg

2 pills a day

Sponsors & Collaborators

  • University of Messina

    lead OTHER

Principal Investigators

  • Rosario D'Anna, professor · University of Messina, ITALY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-07-31
Completion
2013-12-31

Countries

  • Italy

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01047982 on ClinicalTrials.gov