Samimi 2015.
Methods | RCT: IRCT20131226562N16 | |
Participants | 56 women randomised Inclusion criteria: pregnant women 18‐40 years, diagnosed with GDM (1 step 2‐hour 75 g OGTT at 24‐28 weeks GA using ADA 2014 criteria, i.e. fasting glucose ≥ 92 mg/dL,1‐hour ≥ 180 mg/dL and 2‐hour ≥ 153 mg/dL) Exclusion criteria: women requiring insulin therapy, women with PPROM, placental abruption, PE, eclampsia, chronic hypertension, hypothyroidism, urinary tract infection, smokers and those with kidney or liver diseases or those taking oestrogen therapy Characteristics: women had high omega‐6 concentrations Setting: Kashan, Iran (January‐March 2014) |
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Interventions |
SUPPLEMENTATION: EPA + DHA + other omega‐3 versus placebo Group 1: 1000 mg omega‐3 fatty acid (1 ‘pearl’ per day for 6 weeks; the pearl contained 70% LCPUFA (180 mg EPA, 120 mg DHA and 400 mg of other omega‐3 fatty acids)); total number randomised: n = 28 Group 2: placebo (1 ‘pearl’ per day for 6 weeks; the pearl contained 500 mg liquid paraffin); total number randomised: n = 28 Timing of supplementation: 6 weeks from 24‐28 weeks GA All women: asked not to alter their routine physical activity or usual dietary intakes throughout the study and not to consume any supplements other than the 1 provided to them by the investigators DHA + EPA dose/day: low: 120 mg DHA + 120 mg EPA |
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Outcomes |
Women: insulin resistance (HOMA‐IR); HOMA‐B; plasma glucose; QUICKI; lipid profile; dietary records; adherence, CRP (ng/mL) Babies/infants/children: nil |
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Notes |
Funding: Kashan University of Medical Sciences Declarations of interest: none reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization and allocation were concealed from the researchers and participants until the main analyses were completed. A trained midwife at maternity clinic did the randomized allocation sequence, enrolled participants and assigned participants to intervention" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The appearance of placebo ... color, shape, size, and packaging, were identical to omega‐3 fatty acid capsule" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not reported, but probably done. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 3/28 women in each group were lost to follow‐up (omega‐3: 1 insulin therapy and 2 hospitalised); placebo (2 insulin therapy and 1 placental abruption). However results for all 56 women were analysed. |
Selective reporting (reporting bias) | Unclear risk | No baby or child outcomes reported. |
Other bias | Low risk | No clear baseline differences. |