Fish Oil Supplementation on Maternal Health (FOSMAT)
Research type
Research Study
Full title
Maternal DHA supplementation and the impact of inflammation on insulin sensitivity in women at high risk of Gestational Diabetes Mellitus
IRAS ID
148290
Contact name
Enitan Ogundipe
Contact email
Sponsor organisation
Chelsea and Westminster NHS Foundation Healthcare trust
Clinicaltrials.gov Identifier
16/LO/1545, London-Hampstead
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
To explore effects of omega -3 docosahexenoic acid (DHA) and omega-6 Arachidonic acid (AA) supplementation on women at risk of developing gestational diabetes mellitus (GDM) by studying maternal, placental, fetal and infant metabolism. Our hypothesis is that DHA/AA supplementation improves maternal insulin sensitivity, reduces fetal overgrowth, improves placental function and fetal metabolic status. Pregnant women at 12-14 weeks of gestation will be recruited and randomised to two treatment groups; placebo (iron & folate) or DHA/AA supplementation with iron and folate. Maternal metabolic hormones and cytokines will be determined at booking (12-14 weeks) and at the time of their full glucose tolerance test (26-28 weeks). At delivery, placentae and cord blood will be collected for analysis of neonatal metabolic and immune profile, placental inflammation and nutrient transport capacity. Infants will be monitored for the first year of life including birth weight, body fat content and growth (3,9,18 and 24 months). We will perform an MRI scan at term to determine brain development and body fat distribution. We will further study the impact on neonatal/infant and childhood urinary metabolites, microbiome and neurological development. Developmental reviews will be performed at each postnatal visit in addition to a full neurodevelopment assessment at 24 months which will correlated to the findings of the MRI brain scans done at term.
REC name
London - Central Research Ethics Committee
REC reference
16/LO/1680
Date of REC Opinion
6 Oct 2016
REC opinion
Unfavourable Opinion