Haghiac 2015.
Methods | RCT: NCT00957476 | |
Participants | 72 women randomised Inclusion criteria: overweight/obese pregnant women (BMI ≥ 25 at first antenatal visit); singleton pregnancy and GA between 8 weeks and 16 weeks Exclusion criteria: known fetal anomaly, regular intake of fish oil supplements (> 500 mg per week in the previous 4 weeks), daily use of NSAIDs; pre‐existing metabolic disorder such as hypertension, diabetes or hyperthyroidism; allergy to fish or fish products; gluten intolerance; women who are vegetarians and do not eat any fish; planned termination of pregnancy or birth at another hospital; known HIV‐positive, illicit drug or alcohol use during current pregnancy Setting: MetroHealth Medical Center, Ohio, USA (participants recruited September 2009 to August 2011) |
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Interventions |
SUPPLEMENTATION: DHA + EPA versus placebo Group 1: DHA plus EPA (total 2 g/day): 800 mg DHA (22:6n‐3) and 1200 mg EPA (20:5n‐3): 4 capsules (2 x twice a day). Total number randomised: n = 36 (25) Group 2: placebo (2 capsules twice a day); contains wheat germ oil. Total number randomised: n = 36 (25) Timing of supplementation: weeks 10‐16 to term DHA + EPA dose/day: high: 800 mg DHA + 1200 mg EPA |
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Outcomes |
Women/birth: length of gestation; maternal plasma omega‐3 and omega‐6 concentrations; CRP; TLR4, IL6, IL8 (in adipose and placental tissue); glucose concentrations; insulin sensitivity (narrative report only); adiponectin; leptin; spontaneous abortions; stillbirth; gestational diabetes; placental gene expression; placental triglycerides Babies/infants/children: birthweight; neonatal lean mass; fat mass; body fat; pea pod lean mass; pea pod fat mass; pea pod body fat |
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Notes |
Notes relating to intervention: adherence run‐in: consenting eligible women were given 1 week’s supply of placebo capsules; they were not allowed to participate in the trial if they did not return or if they had taken < 50% of the placebo capsules. Funding: NIH RHD057236. Emiment supplied the study supplements. Declarations of interest: "The authors declared that they have no conflicts of interest". |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computerised random number generation |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization and treatment assignment were carried out by the research coordinators" Probably done |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Study group assignment was not known by study participants, their health care providers, or the research staff" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not reported but probably done |
Incomplete outcome data (attrition bias) All outcomes | High risk | 21/72 (29%) attrition: Omega‐3 group, lost 10:
Control group, lost 11:
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Selective reporting (reporting bias) | Unclear risk | Few maternal, birth and neonatal outcomes reported |
Other bias | Unclear risk | Baseline characteristics were similar except for higher average weight (but not BMI) in the omega‐3 group. |