Maternal Fish Oil Supplementation Study in high risk pregnancies
| ISRCTN | ISRCTN24068733 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24068733 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/06/2011
- Registration date
- 02/09/2011
- Last edited
- 26/08/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
The aim of this study is to determine whether providing women with high-risk pregnancies (i.e., with diabetes or at risk of low birth weight) with fish oil supplementation affects the magnetic resonance imaging (MRI) brain findings and development of their infants.
Who can participate?
Pregnant women with high-risk pregnancies with a known or recent diagnosis of diabetes or those at risk of delivering a low birth weight baby.
What does the study involve?
Participants will be randomly allocated to one of two groups. One group will receive fish oil supplements and the other group will receive olive oil, which is known to have health benefits from reports on the Mediterranean diet and longevity. Both groups will receive their routine antenatal care. The mothers will provide blood samples for testing of lipid (fat) profiles and iron status, and will complete questionnaires. The infants born to the mothers in the study groups will also be followed up for assessments including weight, length and head circumference. Cord blood will be taken at delivery to determine their blood lipid levels and stool samples will be obtained. The infants will undergo a brain MRI scan. Visual attention will be determined at each visit and a formal visual test will be undertaken at 9 months of age
What are the possible benefits and risks of participating?
Fish oil supplementation may result in improvement of the lipid profile of mothers and their babies.
Where is the study run from?
Imperial College (UK).
When is study starting and how long is it expected to run for?
The study will run from April 2010 to March 2013.
Who is funding the study?
Mother and Child Foundation (UK).
Who is the main contact?
Dr Enitan Ogundipe
e.ogundipe@imperial.ac.uk
Contact information
Scientific
Neonatal Unit, Chelsea & Westmsinster Hospital
Imperial College
369 Fulham Road
London
SW10 9NH
United Kingdom
| Phone | +44 (0)20 3315 3326 |
|---|---|
| e.ogundipe@imperial.ac.uk |
Study information
| Study design | Double blind randomised placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Maternal Fish Oil Supplementation in high risk pregnancies and the effect on the infants' brain MRI findings and neurobehavioural outcomes |
| Study acronym | FOSS study |
| Study hypothesis | To determine whether maternal fish oil supplementation in women with high risk pregnancies, i.e.diabetes and risk of low birthweight affects the MRI bain findings and developmental outcomes of their infants We postulate that high risk mothers and their fetuses will have lower docosahexaenoic acid (DHA) (in fish oil) levels than controls. Maternal supplementation with fish oil will result in improvement of the lipid profile of mothers and their fetuses. The un-supplemented group of infants will have lower grey matter and total brain volumes on MRI scans which will correlate to the neuro-developmental test scores. Aims: To determine whether lipid profiles and markers of oxidative stress differ between pregnant mothers supplemented with fish oils and those who are not, and if there is a relationship to their infantsÂ’ Brain MRI findings. 2. To determine whether supplementing pregnant and lactating high risk mothers with omega 3 affects the maternal psycho-behavioural outcomes 3. To determine whether supplementing pregnant mothers affects the infant postnatal morbidity, stool microflora, growth and neuro-developmental outcome. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Maternal diabetes mellitus, pre-eclampsia, low birthweight |
| Intervention | 1. Fish oil supplements or placebo 2. MRI infant brain scan 3. Neuro-behavioural assessments of mother and infants |
| Intervention type | Other |
| Primary outcome measure | 1. Infants MRI brain scan findings 2. Maternal lipid profile |
| Secondary outcome measures | 1. Infant developmental outcomes 2. Maternal neurobehavioural outcomes |
| Overall study start date | 01/04/2010 |
| Overall study end date | 31/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 300 pregnant women and their infants |
| Participant inclusion criteria | All pregnant women in high risk pregnancies with known or recent diagnosis of diabetes mellitus or those at risk of delivering a low birthweight baby cared for at the Chelsea & Westminster Hospital, London United Kingdom |
| Participant exclusion criteria | 1. Fish allergy 2. Inability to speak english and refusal to use an interpreter 3. Non-resident in London 4. Unable to attend the follow up appointments |
| Recruitment start date | 01/04/2010 |
| Recruitment end date | 31/03/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SW10 9NH
United Kingdom
Sponsor information
Charity
36 Regents Park Road
London
NW1 7SX
United Kingdom
| Website | http://www.mother-and-child.org |
|---|---|
"ROR" |
https://ror.org/030ybgp98 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
26/08/2016: No publications found, verifying study status with principal investigator
