NCT01047982

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

January 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 28, 2014

Status Verified

February 1, 2014

Enrollment Period

3.3 years

First QC Date

January 12, 2010

Last Update Submit

February 27, 2014

Conditions

Gestational Diabetes

Keywords

gestational diabetesmacrosomiahypertension in pregnancyHOMA-IRobesity

Outcome Measures

Primary Outcomes (2)

  • number of gestational diabetes cases diagnosed with OGTT

    24-28th weeks gestation

  • difference in HOMA values

    from first trimester to OGTT

Secondary Outcomes (1)

  • incidence of pregnancy complications: hypertension, preterm delivery. macrosomia, shoulder dystocia, etc.

    at delivery

Study Arms (2)

myo-inositol

ACTIVE COMPARATOR
Dietary Supplement: myo-inositol

placebo

PLACEBO COMPARATOR

acid folic 400 mcg twice per day

Other: folic acid 400 mcg

Interventions

myo-inositolDIETARY_SUPPLEMENT

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

myo-inositol
folic acid 400 mcgOTHER

2 pills a day

placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Obese pregnant women: BMI \> 30 Kg/cm2
  • first trimester fast glycaemia \< 126 mg/dl
  • single pregnancy

You may not qualify if:

  • Pregnant women with BMI \< 30 Kg/cm2
  • first trimester fast glycaemia \> 126 mg/dl
  • previous gestational diabetes
  • twin pregnancy
  • pregestational diabetes
  • associated therapies with corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetrics and Gynecology Unit, University of Messina and Obstetrics and Gynecology Unit of Modena University

Messina and Modena, Italy

Location

Related Publications (2)

  • Motuhifonua SK, Lin L, Alsweiler J, Crawford TJ, Crowther CA. Antenatal dietary supplementation with myo-inositol for preventing gestational diabetes. Cochrane Database Syst Rev. 2023 Feb 15;2(2):CD011507. doi: 10.1002/14651858.CD011507.pub3.

    PMID: 36790138DERIVED

  • D'Anna R, Di Benedetto A, Scilipoti A, Santamaria A, Interdonato ML, Petrella E, Neri I, Pintaudi B, Corrado F, Facchinetti F. Myo-inositol Supplementation for Prevention of Gestational Diabetes in Obese Pregnant Women: A Randomized Controlled Trial. Obstet Gynecol. 2015 Aug;126(2):310-315. doi: 10.1097/AOG.0000000000000958.

    PMID: 26241420DERIVED

MeSH Terms

Conditions

Diabetes, GestationalHypertension, Pregnancy-InducedObesity

Interventions

InositolFolic Acid

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHypertensionVascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Rosario D'Anna, professor

    University of Messina, ITALY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 12, 2010

First Posted

January 13, 2010

Study Start

March 1, 2010

Primary Completion

July 1, 2013

Study Completion

December 1, 2013

Last Updated

February 28, 2014

Record last verified: 2014-02

Locations

IT(1)