Boris 2004.
Methods | Further randomisation (4 arms) of Olsen 1992 (supplementation until birth versus supplementation until 30 days after giving birth) | |
Participants | 44 women randomised Inclusion criteria: healthy pregnant women Exclusion criteria: not reported Setting: Aarhus, Denmark |
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Interventions |
SUPPLEMENTATION: omega‐3 (until birth) versus omega‐3 (continuing for 30 days after giving birth) versus olive oil versus no supplementation Group 1: omega‐3 (1.3 g EPA and 0.9 g DHA per day) as 4 x 1 g gelatine capsules with Pikasol (Lube A/S, Hadsund, Denmark) fish oil (32% EPA (20:5n‐3), 23% DHA, and 2 mg tocopherol/mL), stopping at birth: n = 11 Group 2: omega‐3 (1.3 g EPA and 0.9 g DHA per day) as 4 x 1 g gelatine capsules with Pikasol (Lube A/S, Hadsund, Denmark) fish oil (32% EPA (20:5n‐3), 23% DHA, and 2 mg tocopherol/mL), stopping 30 days after giving birth: n = 12 Group 3: 4 x 1 g capsules of olive oil per day (72% oleic acid (18:1n‐9) and 12% LA (18:2n‐6)), stopping at birth: n = 8 Group 4: no supplement, stopping 30 days after giving birth: n = 5 Timing of supplementation: from 30 weeks GA until birth or 30 days after giving birth DHA + EPA dose/day: high: 900 mg DHA + 1300 mg EPA |
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Outcomes | Omega‐3 and lipid concentrations in breast milk | |
Notes |
Funding: The University of Aarhus (Aarhus, Denmark); Lube A/S ((Hadsund, Denmark), supplied Pikasol fish oil and olive oil capsules. Declarations of interest: not reported No outcomes able to be used in this review. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomly allocated" |
Allocation concealment (selection bias) | Unclear risk | Quote: "randomly allocated" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Partial (one group not supplemented; timing for omega‐3 groups not able to be blinded) |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | 3/26 in the intervention groups and 6/18 in the control groups were lost to follow‐up (no reasons reported) |
Selective reporting (reporting bias) | Unclear risk | Insufficient detail reported to determine confidently |
Other bias | Low risk | Groups were similar for baseline characteristics with regard to maternal age at birth, and prepregnancy weight |