Garg 2017.

Trial name or title	Omega‐3 fish oil for the prevention of gestational diabetes
Methods	RCT: ACTRN12617000177358
Participants	Recruitment target: 74 women Inclusion criteria: < 14 weeks pregnant; aged 18‐40; with any 1 of the following: a) PAPP‐A between 0.3 and 0.6 MoM in their Nuchal Translucency Scan b) previous history of gestational diabetes c) at risk of developing gestational diabetes Exclusion criteria: BMI greater than 45 kg/m2; any incidence of ongoing bleeding beyond 8 weeks' gestation in the current pregnancy; on anti‐coagulant therapy or known to have clotting disorders; known to be pregnant with multiples; lactating; established diabetes prior to pregnancy or currently taking anti‐diabetic medications; being diagnosed with gestational diabetes in this pregnancy prior to enrolment in the study; known allergies to seafood or corn; currently on medication with aspirin and warfarin; has significant current gastrointestinal disease; incapable of giving informed consent; history of new investigational drug 3 months prior to this trial; currently consuming more than 200 g oily fish per week or taking supplements delivering 150 mg or more of DHA/day; unable to fast for 10 hr before obtaining blood sample Setting: John Hunter Hospital, Newcastle, Australia
Interventions	Intervention group 2 x 1 g fish oil capsules each day (each capsule containing 60mg eicosapentaenoic acid and 430 mg DHA) from ˜ 14 weeks' gestation until 34 weeks' gestation Control group Placebo: 1 x 1 g corn oil capsules/day from ˜ 14 weeks' gestation until 34 weeks' gestation
Outcomes	Primary outcome: insulin resistance, as measured by HOMA‐IR fasting glucose X fasting insulin/22.5 (at 14, 20, 28 & 34 weeks' gestation). Other outcomes: plasma inflammatory markers (IL‐6, TNF‐alpha, CRP, IL‐1beta) and adipokines (adiponectin, leptin), measured using ELISA assays (at 14, 20 & 34 weeks' gestation); blood pressure (at 14, 20 & 34 weeks' gestation); newborn whole‐blood fatty acid composition (48‐72 hours after birth); Matsuda Index (calculated from 2 hour oral glucose tolerance test at 28 weeks' gestation); erythrocyte fatty acid composition, measured by gas chromatography from a fasting blood sample (at 14, 20 & 34 weeks' gestation)
Starting date	1 March 2017
Contact information	Prof Manohar Garg, University of Newcastle. E‐mail: manohar.garg@newcastle.edu.au
Notes	Funding and collaborators: University of Newcastle, Australia and EPAX, Norway.