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
What does the study involve?
Participants are randomly allocated to one of two groups: the intervention group or the placebo (dummy) group. The intervention group take one tablet every day containing Inositol combined with folic acid and the placebo group take folic acid alone. They then follow standard care and be tested as routine for gestational diabetes at 26 weeks. If they have diabetes they attend the diabetes clinic and if not they follow standard care. Their pregnancy is followed until delivery. The type of delivery they have, the weight or their baby and any complications for themselves or their baby are 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 Coombe Women and Infant's University Hospital (Ireland)
When is the study starting and how long is it expected to run for?
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
Study website
Additional identifiers
EudraCT/CTIS number
2013-003572-12
IRAS number
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.
Ethics approval(s)
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
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details 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
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
D-chiro-inositol, folic acid
Primary outcome measure
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 study start date
01/11/2013
Overall study end date
01/02/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Any woman aged over 18 booking before 14 weeks with a first-degree relative who has diabetes
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
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
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2017 | Yes | No |