Chase 2015.
| Methods | RCT (pilot): NCT00333554 | |
| Participants | 41 infants (randomised during pregnancy). A further 21 mothers (˜33%) received either DHA or placebo during their last trimester, but discontinued post birth. Inclusion criteria: women 18 years of age or older, from 24 weeks GA whose babies may be at higher risk for T1D based on family history (had T1D, or child’s father or a full or half sibling of the child had T1D) Exclusion criteria: any condition investigators believed would put the mother or her fetus at an unacceptable medical risk; known complication of pregnancy causing an increased risk for the mother of fetus prior to entry into the study; have previously had 2 or more preterm births (< 36 weeks); were diabetic and had a known HbA1c > 9% at any time during the pregnancy, plan to take DHA during the pregnancy Setting: 9 clinical sites across USA |
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| Interventions |
SUPPLEMENTATION: DHA versus placebo Group 1: algal DHA daily while pregnant and lactating (if choosing to breastfeed); 800 mg DHA per day (4 capsules); infant received ˜ 150 mg/day from mother or from formula; then 400 mg/day as toddlers (1‐2 years of age): total number randomised: n = unclear (21 reported) Group 2: corn/soy oil (placebo): total number randomised: n = unclear (16 reported) Timing of supplementation: supplementation began immediately after randomisation (start of third trimester of pregnancy) and continued at least until the HLA type of the infant was known; if an infant entered the study antenatally, duration of supplementation would be a minimum of 36 months DHA + EPA dose/day: mid: 800 mg DHA + EPA negligible |
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| Outcomes |
Women/birth: breastmilk DHA Babies/infants/children: RBC DHA, IL 1‐betaC, CRP and other inflammatory mediators; infant vitamin D |
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| Notes |
Funding: NIDDK branch of the NIH, the ADA, and the Juvenile Diabetes Research Foundation (JDRF). Supplements from DHASCO‐S oil, Martek Biosciences Corporation, Columbia, MD Declarations of interest: not reported No outcomes could 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 | Not reported |
| Allocation concealment (selection bias) | Unclear risk | Quote: "randomly assigned" |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "double blinded" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not fully reported |
| Selective reporting (reporting bias) | Unclear risk | Limited number of outcomes reported |
| Other bias | Unclear risk | Insufficient information to determine |