de Groot 2004.
Methods | RCT: parallel | |
Participants | 79 women randomised Inclusion criteria: white origin, GA < 14 weeks, normal health (not suffering from any hypertensive, metabolic, cardiovascular, renal, psychiatric, or neurologic disorder), fish consumption < 2 times per week Exclusion criteria: DBP > 90 mmHg, multiple pregnancy, use of medications, use of (LC)PUFA rich supplements, origin other than Caucasian Setting: region around Maastricht, Heerlen and Sittard in the Netherlands |
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Interventions |
SUPPLEMENTATION/ENRICHMENT: ALA + LA versus LA (in margarine) Group 1: ALA: daily ≥ 25 g ALA‐enriched high‐LA margarine from week 14 of pregnancy until birth (with the requested intake of 25 g margarine/day women consumed 2.82 g ALA + 9.02 g LA per day) ‐ 40 women randomised; 29 analysed Group 2: No ALA: daily ≥ 25 g of high‐LA margarine without ALA from week 14 of pregnancy until birth (with the requested intake of 25 g of margarine/day women consumed 10.94 g LA and 0.03 g ALA per day) ‐ 39 women randomised; 29 analysed All women: every 3 weeks the volunteers received 3 tubs each containing 250 g margarine. Women were instructed to consume the margarine primarily on bread (if consumption was lower than required, they were advised to put it on top of potatoes or pasta; they were not allowed to use it for baking because of possible adverse effects on the polyunsaturated fatty acid content of the margarine). They were allowed to maintain their usual diets during the course of the study, with the exception of the use of butter/their usual margarine. Timing of supplementation: from 14 weeks GA to birth DHA + EPA dose/day: other (2.82 g ALA) |
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Outcomes |
Women/birth: maternal cognitive functioning; caesarean section; gestational diabetes; depression (postnatal); antenatal admission to hospital (long‐term hospitalisation); gestational length; fatty acid concentrations; breastfeeding Babies/infants/children: preterm birth < 36 weeks; stillbirth; birthweight; Apgar score |
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Notes |
Funding: grant from Unilever Research and Development (Vlaardingen, Netherlands), which also donated the margarines used in the study. Declarations of interest: none declared by authors of main reference, not reported in other references |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomly allocated"; no further details reported |
Allocation concealment (selection bias) | Unclear risk | Quote: "randomly allocated"; no further details reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Described as "double blind"; no further details reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | 21/79 (27%) women were lost to follow‐up: 11 from the ALA group:
10 in the no ALA group:
After giving birth, a further 2 women were lost to follow‐up, both in the ALA group (1 moved away; 1 postnatal depression). |
Selective reporting (reporting bias) | Unclear risk | Not all expected outcomes were reported; some outcomes treated as exclusions and therefore may be incompletely reported |
Other bias | Unclear risk | More breastfeeding mothers in the ALA group |