Jamilian 2017.
Methods | RCT (4 arms, see below) | |
Participants | 140 women randomised Inclusion criteria: women 18‐40 years; without prior diabetes; diagnosed with GDM by 1‐step 2‐hour 75‐g OGTT at 24‐28 weeks’ gestation referred to Kosar Clinic in Arak, Iran. GDM was diagnosed according to the ADA guidelines: those whose plasma glucose met 1 of the following criteria were considered as having GDM: FPG ≥ 92 mg/dL, 1‐hour OGTT ≥ 180 mg/dL, and 2‐hour OGTT ≥ 153 mg/dL. Exclusion criteria: taking vitamin D and/or omega‐3 fatty acid supplements; taking insulin; placental abruption; PE; hypothryroidism and hyperthyroidism; smokers; those with kidney or liver disease Setting: Kosar Clinic, Arak, Iran; women were recruited from March 2016 to July 2016 |
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Interventions |
SUPPLEMENTATION + OTHER AGENT: omega‐3 versus omega‐3 + vitamin D versus vitamin D versus placebo Group 1: omega‐3 fatty acids (2000 mg; 720 mg EPA and 480 mg DHA per day) as 2 capsules (produced by Zahravi Pharmaceutical Company, Tabriz, Iran): n = 35 randomised (n = 32 completed study) Group 2: omega‐3 fatty acids (2000 mg; 720 mg EPA and 480 mg DHA per day) as 2 capsules plus vitamin D (50,000 IU every 2 weeks): n = 35 randomised (and completed study) Group 3: vitamin D (50,000 IU every 2 weeks) plus omega‐3 placebo capsules: n = 35 randomised (and completed study) Group 4: no supplement (placebo) as 2 capsules that were indistinguishable in colour, shape, size, and packaging, smell, and taste from the vitamin D and omega‐3 fatty acids capsules: n = 35 randomised (32 completed study) Timing of supplementation: 6 weeks (start 24‐28 weeks' gestation) DHA + EPA dose/day: high: 480 mg DHA + 720 mg EPA |
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Outcomes | Women/birth: insulin metabolism (primary); lipid concentrations (secondary) | |
Notes | No outcomes could be included in this review. Funding: grant from the Vice‐Chancellor for Research, AUMS (no.1394.373) Declarations of interest: none declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random sequence generation was ensured using a computer‐generated random numbers table. |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "appearance of placebo capsule was indistinguishable in color, shape, size, and packaging, smell, and taste from Vitamin D and omega‐3 fatty acids capsules"; considering the nature of intervention and placebo, participants and personnel could have been effectively blind to group assignments throughout the trial. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 140 women were randomised, 35 each to: placebo; vitamin D; omega‐3; and vitamin D + omega‐3. A total of 6 women (3 placebo group, 3 omega‐3), were lost to follow‐up, leaving 134/140 (97%) women randomised in the data collection. The difference in the proportions of randomised women included in the data collection was marginal: 100% of women in the vitamin D and vitamin D + omega 3 groups; and 91% of the women in the remaining 2 groups. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information for confident assessment |
Other bias | Low risk | Baseline characteristics similar; no obvious other bias identified |