Van Goor 2009.
Methods | RCT: ISRCTN58176213 | |
Participants | 183 women randomised (3 groups ‐ see below) Inclusion criteria: apparently healthy women with a low‐risk first or second pregnancy Exclusion criteria: preterm births (< 37 weeks) or GA > 42 weeks and any maternal or neonatal complications; vegetarians or vegans Characteristics: low background DHA intake (fish intake once a week) Setting: Groningen, the Netherlands: assumed to be during antenatal care (recruited by midwives and obstetricians) |
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Interventions |
SUPPLEMENTATION: DHA + AA versus DHA versus placebo Group 1: DHA + AA (220 mg each/day): total number randomised: 58 (41) Group 2: DHA (220 mg/day) + 1 soy capsule/day: 63 (41) Group 3: placebo (2 soy capsules/day); equivalent to 535 mg LA/day: total number randomised: n = 62 (36) Timing of supplementation: mean 16.5 weeks GA (range 14‐20 weeks) till 12 weeks postpartum (formula not supplied if child not breast fed) DHA + EPA dose/day: low: 220 mg DHA |
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Outcomes |
Women/birth: preterm birth; GA; GDM; fatty acids in plasma (at 16 and 36 weeks GA); EPDS at 16 and 36 weeks GA and 6 weeks pp; blues questionnaire within 1 week pp; DHA and AA in breastmilk (2 and 12 weeks pp); sleep quality (36 weeks GA and 4 weeks pp); Obstetric Optimality Score (74 items covering socioeconomic status, non‐obstetric conditions during pregnancy, obstetric history, diagnostic and therapeutic measures, parturition and neonatal condition immediately after birth; food frequency questionnaires (16 and 36 weeks GA, 12 weeks pp); fatty acids (in umbilical cord); birthweight; duration of breastfeeding Babies/infants/children: general movement quality; NOS; Hempel neurological examination; BSID II (Dutch version); weight at 18 months; height at 18 months; head circumference at 18 months; cerebral palsy (EPDS and Hempel reported as median and ranges only) |
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Notes |
Funding: Friesland Foods, the Netherlands Declarations of interest: none declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Block randomisation; not further reported |
Allocation concealment (selection bias) | Unclear risk | Quote: “randomized into three groups” |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind placebo‐controlled |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | 58/183 (32%) “lost interest” (23 placebo; 20 DHA; 15 DHA/AA); 6 pregnancy complications (3 placebo, 1 DHA, 2 DHA/AA), leaving 119 for analysis |
Selective reporting (reporting bias) | Low risk | Most expected outcomes were reported (although numbers per group were not reported for EPDS > 12 and blues score > 12) |
Other bias | Low risk | Baseline characteristics similar |