Condition category
Pregnancy and Childbirth
Date applied
19/09/2013
Date assigned
31/10/2013
Last edited
21/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Gestational diabetes mellitus is a form of diabetes that can occur in pregnancy. This can affect both mother and baby during the course of the pregnancy and delivery. Inositol is a food supplement which has been shown in small studies to have health benefits including reducing the incidence of gestational diabetes in those at risk of getting it. The aim of our study is to find out the possible health benefits of Inositol for women at risk. This includes finding out if they have a decreased incidence of gestational diabetes, if they have fewer complications during delivery, if their baby's weight is affected and if their baby's first few days of life is affected.

Who can participate?
Women who are 10-14 weeks pregnant and who are at risk of developing gestational diabetes due to a family history of diabetes, can participate in the study.

What does the study involve?
Participants will be randomly allocated to one of two groups: the intervention group or the placebo (dummy) group. The intervention group will take one tablet every day containing Inositol combined with folic acid and the placebo group will take folic acid alone. They will then follow standard care and be tested as routine for gestational diabetes at 26 weeks. If they have diabetes they will attend the diabetes clinic and if not they will follow standard care. Their pregnancy will be followed until delivery. The type of delivery they have, the weight or their baby and any complications for themselves or their baby will be recorded.

What are the possible benefits and risks of participating?
The benefit of participating in this study is that it may have health benefits for them. There are no expected risks in participating. Studies have not shown any side effects of Inositol at the doses we are using.

Where is the study run from?
The study will be run in the Coombe Women and Infant's University Hospital, Ireland.

When is the study starting and how long is it expected to run for?
The study is expected to run from November 2013 to June 2015.

Who is funding the study?
The Coombe Women and Infants University Hospital, Ireland.

Who is the main contact?
Dr Maria Farren
mariafarren1983@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sean Daly

ORCID ID

Contact details

Coombe Women and Infant's University Hospital
Cork Street
Dublin
8
Ireland

Additional identifiers

EudraCT number

2013-003572-12

ClinicalTrials.gov number

Protocol/serial number

15-2013

Study information

Scientific title

A randomised controlled trial to investigate the role of myoinositol and D-chiro-inositol (in physiological ratio 40:1) in the general health of those at risk of developing gestational diabetes mellitus

Acronym

Study hypothesis

Current hypothesis as of 09/04/2014:
Inositol has been shown to have health benefits in those at risk of diabetes mellitus. We wish to investigate the effect of inositol on those who, by virtue of a positive family history of diabetes mellitus, are at risk of developing gestational diabetes mellitus.

Previous hypothesis:
Inositol has been shown to have health benefits in those at risk of diabetes mellitus. We wish to investigate the effect of two different forms of inositol on those who, by virtue of a positive family history of diabetes mellitus, are at risk of developing gestational diabetes mellitus.

On 21/07/2015 the overall trial end date was changed from 01/06/2015 to 01/02/2016.

Ethics approval

Coombe Women and Infants University Hospital Research Ethics board, 18/09/2013, ref: 18/10/13

Study design

Single-blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Gestational diabetes mellitus

Intervention

Current interventions as of 09/04/2014:

Participants will be randomized to one of the following two groups:
1. Intervention group. This group will take D-chiro-inositol (11.8 mg) and folic acid (400 mcg) in combination
2. Control group. This group will take 400 mcg of folic acid

All of the above is dose per day. The duration of treatment is from recruitment at 10-14 weeks until delivery. They will be followed up until 6 weeks postnatally.

Previous interventions:
There are two intervention arms and one placebo:
1. Myoinositol 4 g + 400 mcg folic acid
2. 550mg myoinositol + 13.8 mg D-chiro-inositol + 400 mcg folic acid in soft gel caps
3. Placebo group: folic acid alone 400mcg

All of the above is dose per day. The duration of treatment is from recruitment at 10-14 weeks until delivery. They will be followed up until 6 weeks postnatally.

Intervention type

Drug

Phase

Not Applicable

Drug names

1. Myoinositol
2. D-chiro-inositol

Primary outcome measures

Development of gestational diabetes mellitus, measured at 26 weeks gestation

Secondary outcome measures

1. Mode of delivery of the baby
2. Birth weight
3. Incidence of maternal or newborn morbidities

All of the above are recorded at delivery.

Overall trial start date

01/11/2013

Overall trial end date

01/02/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Any woman aged over 18 booking before 14 weeks with a first-degree relative who has diabetes

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

489

Participant exclusion criteria

1. Multiple pregnancy
2. Known or suspected congenital abnormality
3. Any disease effecting the liver or pancreas

Recruitment start date

18/11/2013

Recruitment end date

10/07/2015

Locations

Countries of recruitment

Ireland

Trial participating centre

Coombe Women and Infant's University Hospital
Dublin
8
Ireland

Sponsor information

Organisation

Coombe Women and Infant's University Hospital (Ireland)

Sponsor details

Cork Street
Dublin
8
Ireland

Sponsor type

Hospital/treatment centre

Website

http://www.coombe.ie/

Funders

Funder type

Hospital/treatment centre

Funder name

Coombe Women and Infants University Hospital (Ireland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes