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Register:	ISRCTN
Last refreshed on:	19 March 2018
Main ID:	ISRCTN92466608
Date of registration:	31/10/2013
Prospective Registration:	Yes
Primary sponsor:	Coombe Women and Infant's University Hospital (Ireland)
Public title:	A trial to investigate the role of the food supplement inositol in the general health of those at risk of developing gestational diabetes mellitus
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
Date of first enrolment:	18/11/2013
Target sample size:	489
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN92466608
Study type:	Interventional
Study design:	Single-blinded randomised controlled trial (Treatment)
Phase:	Not Applicable

Countries of recruitment
Ireland

Contacts

Name:	Sean Daly
Address:	Coombe Women and Infant's University Hospital Cork Street 8 Dublin Ireland
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: Any woman aged over 18 booking before 14 weeks with a first-degree relative who has diabetes
Exclusion criteria: 1. Multiple pregnancy
2. Known or suspected congenital abnormality
3. Any disease effecting the liver or pancreas

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Gestational diabetes mellitus
Pregnancy and Childbirth
Diabetes mellitus arising in pregnancy

Intervention(s)

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.

Primary Outcome(s)

Development of gestational diabetes mellitus, measured at 26 weeks gestation

Secondary Outcome(s)

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.

Secondary ID(s)

2013-003572-12

15-2013

Source(s) of Monetary Support

Coombe Women and Infants University Hospital (Ireland)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

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

Results

Results available:	Yes
Date Posted:
Date Completed:	01/02/2016
URL:

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