West 2014

Methods	Community‐based, cluster‐randomised, double‐blind trial to examine whether a daily antenatal and postnatal MMN supplement given to women will enhance newborn and infant survival and health and other birth outcomes in a rural setting in northwestern Bangladesh.
Participants	Pregnant women, aged 12‐45 years, consenting to participate were recruited (n = 45,000). Women not interviewed for consent within 12 consecutive weeks after being ascertained as pregnant by urine testing were excluded.
Interventions	Dietary supplement: MMN containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B‐12 (2.6 mg), vitamin B‐6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug). Control supplement contained iron (27 mg) ‐ folic acid (600 ug) (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks postpartum.
Outcomes	Infant mortality through 6 months of age, perinatal mortality, neonatal mortality, birth size (weight, length, circumferences), gestational age at birth, infant health outcomes, maternal morbidity, obstetric complications, body composition, nutritional status. Christian 2014a reports length‐for‐age Z score and stunting at 1 and 3 months in an abstract.
Notes	The composition of the MMN supplement followed the UN MMN preparation, except with higher amounts as needed to meet the RDA from the Institute of Medicine. The substudy area was selected to be representative of the parent trial across a range of factors, including sociodemographic and geographic variations, which were evaluated during an earlier trial in the same area.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomized", "study area was divided into 596 sectors of comparable size that were used as units of randomization". Comment: probably done.
Allocation concealment (selection bias)	Unclear risk	Quote: "cluster‐randomized", "Allocation: Randomized". Comment: insufficient information to permit judgement.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Complete information was not available as the main trial has not been published; however, attrition is reported to be < 20% (trial presentations).
Selective reporting (reporting bias)	Low risk	Comment: reports from the study are still being published.
Other bias	Low risk	Comment: no other bias was identified.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "double‐masked", "Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)", "received daily supplementation, so treatment effect (still blinded due to the ongoing trial)". Comment: probably done.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "double‐masked", "Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)", "received daily supplementation, so treatment effect (still blinded due to the ongoing trial)". Comment: probably done.