A trial to investigate the role of the food supplement inositol in the general health of those at risk of developing gestational diabetes mellitus
| ISRCTN | ISRCTN92466608 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92466608 |
| EudraCT/CTIS number | 2013-003572-12 |
| Secondary identifying numbers | 15-2013 |
- Submission date
- 19/09/2013
- Registration date
- 31/10/2013
- Last edited
- 15/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
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
Contact information
Scientific
Coombe Women and Infant's University Hospital
Cork Street
Dublin
8
Ireland
Study information
| Study design | Single-blinded randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| 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 |
| 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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 489 |
| Participant inclusion criteria | Any woman aged over 18 booking before 14 weeks with a first-degree relative who has diabetes |
| 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
8
Ireland
Sponsor information
Hospital/treatment centre
Cork Street
Dublin
8
Ireland
| Website | http://www.coombe.ie/ |
|---|---|
"ROR" |
https://ror.org/00bx71042 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2017 | Yes | No |
Editorial Notes
15/02/2018: Publication reference added.
21/07/2015: The overall trial end date was changed from 01/06/2015 to 01/02/2016.
