Gustafson 2013.

Methods	RCT: NCT01007110 (HOPE)
Participants	67 women randomised Inclusion criteria: women 16 to < 40 years old with a singleton pregnancy, 12‐20 weeks GA Exclusion criteria: any serious health condition likely to affect the growth and development of the fetus or the health of the mother including cancer, lupus, hepatitis, diabetes mellitus (type 1, 2 or gestational) or HIV/AIDS at baseline. Women who self‐reported illicit drug use or alcohol use during pregnancy and those with hypertension or BMI ≥ 40 were excluded. Women who were taking more than 200 mg/day DHA in prenatal vitamins or over‐the‐counter supplements were excluded from participation. Setting: Kansas City, Kansas, USA
Interventions	SUPPLEMENTATION: DHA versus placebo Group 1: DHA 600 mg/day: contained 500 mg of oil: algal oil as a source of DHA (200 mg of DHA per capsule; 3 capsules a day): total number randomised = 35 Group 2: placebo (3 placebo capsules a day containing 50% soy and 50% corn oil): total number randomised = 32 Timing of supplementation: 14.4 weeks GA ± 4 weeks; women were advised to stop taking capsules once they had given birth DHA + EPA dose/day: mid: 600 mg DHA + EPA negligible
Outcomes	Women/birth: DHA RBC concentrations; GA at birth Babies/infants/children: fetal heart rate, heart rate variability (at 24, 32 and 36 weeks GA); birthweight; birth length; DHA RBC concentrations; NBAS at 1‐14 days postpartum
Notes	Funding: Eunice Kennedy Shriver National Institute of Child Health and Development, Kansas Intellectual Development and Disabilities Research Center; study product donated by DSM Nutritional Products (P30NICHDHD002528). Declarations of interest: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random sequence
Allocation concealment (selection bias)	Low risk	Quote: “only members of the investigational pharmacy knew the subject allocation”
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participants and all members of the investigational team were blinded to the intervention assignment.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not reported ‐ insufficient information to make any judgement.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	33% loss to follow‐up overall: to birth (23/69): In the control group, 8/32 (25%): 3 withdrawals 1 did not meet inclusion criteria 1 miscarriage 1 high‐risk pregnancy 1 congenital anomalies 1 preterm birth In the DHA group: 13/35 (37%): 1 fetal demise 1 miscarriage 6 lost contact/transferred 1 withdrawal 1 excessive morning sickness 1 cholelithiasis 1 miscalculated due date 1 preterm birth NBAS: a further 12 from the control group and a further 7 from the DHA group did not have NBAS assessments
Selective reporting (reporting bias)	High risk	Few maternal and birth outcomes reported
Other bias	Low risk	Maternal characteristics at trial entry were similar, no other sources of bias were apparent.