Osrin 2005

Methods	This study was undertaken in Nepal. All women attending a designated antenatal clinic at Janakpur zonal hospital were considered for enrolment.
Participants	Women were eligible for enrolment if an ultrasound examination confirmed a singleton pregnancy, a gestational age between 12 to 20 completed weeks, no notable fetal abnormality, no existing maternal illness of a severity that could compromise the outcome of pregnancy; and the participant lived in an area of Dhanusha or the adjoining district of Mohattari accessible for home visits. Participants received supplements throughout pregnancy until delivery.
Interventions	The MMN group (n = 600) received tablets containing vitamin A 800 mcg, vitamin E 10 mg, vitamin D 5 mcg, B1 1.4 mg, B2 1.4 mg, niacin 18 mg, B6 1.9 mg, B12 2.6 mcg, folic acid 400 mcg, vitamin C 70 mg, iron 30 mg, zinc 15 mg, copper 2 mg, selenium 65 mcg, and iodine 150 mcg. Control group (n = 600) received tablets containing iron 60 mg and folic acid 400 mcg. There were 2 prespecified deviations from the protocol: if a participant's enrolment blood Hb concentration was less than 70 g/L, she was given an extra 60 mg of iron daily, anthelmintic treatment, and her Hb was rechecked after 1 month; and if a participant described night blindness at any time, she was given 2000 ug of vitamin A daily and referred for medical follow up.
Outcomes	Birthweight, LBW (< 2500 g), gestational duration, preterm delivery (< 37 weeks of gestation), miscarriage, stillbirth, early and late neonatal death, infant length, head circumference. It should be noted that the data for SGA was obtained from a separate report (Food and Nutrition Bulletin 2009) and not from the individual trial report.
Notes	Infants were followed up to 3 months. Both groups of participants were comparable at baseline. There is a discrepancy in the number of neonatal deaths reported. Figure: 'Study profile' in the Devakumar 2014 Lancet publication (p e655) reports 12 neonatal deaths in the control group and Osrin 2005 reports 11 neonatal deaths in the control group.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomly allocated 1200 participant identification numbers by computer into two groups in permuted blocks of 50". Comment: probably done.
Allocation concealment (selection bias)	Low risk	Quote: "We did randomisation in advance of recruitment", "The allocation code was kept on file in Kathmandu and London. We allocated every identification number a supplement container to last throughout the trial. Containers were filled with either intervention or control tablets in Kathmandu by a team member who was otherwise uninvolved in the trial; these containers were then marked only with identification numbers and transported to the study centre in Janakpur" and "After screening, consent, and enrolment, one of us (YS) allocated participants sequential identification numbers and the corresponding supplement containers". Comment: probably done.
Incomplete outcome data (attrition bias) All outcomes	High risk	Attrition was 5% and reasons for it were reported. Exclusion was 39.5% and reasons were not reported.
Selective reporting (reporting bias)	Low risk	Comment: all outcomes mentioned in the methods section were presented in the paper.
Other bias	Low risk	Comment: no other bias was identified.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "The allocation code was kept on file in Kathmandu and London" and "Containers were filled with either intervention or control tablets in Kathmandu by a team member who was otherwise uninvolved in the trial; these containers were then marked only with identification numbers and transported to the study centre in Janakpur. Intervention and control supplements were manufactured to look, smell, and taste identical". Comment: participants and caregivers were probably blinded to the treatment assignment.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The allocation code was kept on file in Kathmandu and London" and "Containers were filled with either intervention or control tablets in Kathmandu by a team member who was otherwise uninvolved in the trial; these containers were then marked only with identification numbers and transported to the study centre in Janakpur. Intervention and control supplements were manufactured to look, smell, and taste identical". Comment: outcome assessors were probably blinded to the treatment assignment.