Fish Oil Supplementation On Maternal Health (FOSMAT)
Research type
Research Study
Full title
The impact of maternal Docosahexaenoic acid (DHA) and Arachodonic acid (ArA) supplementation on inflammation and insulin sensitivity in women at high risk of Gestational Diabetes Mellitus (GDM)
IRAS ID
218619
Contact name
Enitan Ogundipe
Contact email
Sponsor organisation
Chelsea & Westminster NHS Foundation Healthcare Trust
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
To explore effects of omega -3 docosahexaenoic acid (DHA) and omega-6 Arachidonic acid (ArA) supplementation on women at risk of developing gestational diabetes mellitus (GDM) by studying maternal, placental, fetal and infant metabolism. Our hypothesis is that DHA/ArA 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 tablet and vegetable oil capsule) or treatment (Iron and folate with DHA/AA fish il capsule). 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 two years 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 - City & East Research Ethics Committee
REC reference
17/LO/0651
Date of REC Opinion
20 May 2017
REC opinion
Unfavourable Opinion