Smuts 2003a.

Methods	RCT
Participants	350 women randomised Inclusion criteria: singleton pregnancies, women aged 16‐36 years; 24‐28 weeks' gestation at enrolment; able and willing to consume eggs; access to refrigeration Exclusion criteria: weight > 109 kg at baseline; serious illness such as cancer, lupus, hepatitis; known to have any untreated serious infectious disease; diabetes or gestational diabetes at baseline; elevated BP attributed to any cause Characteristics: most women were socially disadvantaged, and most were African‐American (73%). Setting: Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, Kansas, USA
Interventions	OMEGA‐3‐ENRICHED FOOD: DHA‐enriched eggs versus CONTROL (ordinary eggs) Group 1: DHA‐enriched eggs: each egg had 133 mg DHA. Women were asked to eat 12 eggs per week but reported eating 5.5 per week (731.5 mg DHA): n = 176 randomised (142 could be analysed) Group 2: ordinary eggs: each egg had 33 mg DHA. Women were asked to eat 12 eggs per week but reported eating 5.4 per week (178.2 mg DHA): n = 174 randomised (149 could be randomised) Timing of supplementation: 24‐28 weeks GA to birth DHA + EPA dose/day: low: 100 mg DHA/day; EPA not stated
Outcomes	Women/birth: gestational diabetes; PE/eclampsia; duration of gestation, preterm birth (< 37 weeks); caesarean; maternal RBC phospholipid DHA concentration at enrolment and at birth Babies/infants/children: birthweight; birth length, head circumference; low birthweight; meconium staining; admissions to neonatal care; neonatal RBC phospholipid DHA concentration at birth; serious adverse events (life‐threatening event, inpatient hospitalisation, or prolonging of an existing hospitalisation, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect
Notes	Initial sample size was 285. Because there were no published data for low‐level DHA supplementation on which to base a power analysis, a blinded review of the data was undertaken after the first 100 births to refine power analysis. Sample size was increased to 350 after the blinded analysis. Funding: OmegaTech Inc, Colorado, USA Declarations of interest: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation schedule
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "double blinded"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Outcome assessments were blinded
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Overall 59/350 (16.9%) lost to follow‐up: DHA‐enriched eggs group lost 34/176 (19.3%): 6 moved 7 withdrew consent 2 never received eggs 6 birthed elsewhere 1 second pregnancy 1 low age 11 unknown reasons Ordinary eggs group lost 25/174 (14.4%): 4 moved 5 withdrew consent 1 never received eggs 1 birthed elsewhere 1 second pregnancy 13 unknown reasons
Selective reporting (reporting bias)	Low risk	Most expected outcomes were reported.
Other bias	Low risk	Baseline characteristics similar in each group.