Methods	Study design: Randomized controlled trial
	Unit of randomization: Individually randomised
	Type of study: Food Distribution Program
Participants	Location/setting: One public district hospital in Mangochi, one semi‐private hospital in Malindi and 2 Public health centres in Lungwena and Namwera in Mangochi District of Malawi
	Population: Not specified
	Sample size: 1391
	Drop outs/withdrawal: 84 IFA (n = 26), LNS (n = 26)
	Socio‐demographics
	Mean (SD) age: LNS: 25 (6), IFA: 25 (6)
	Occupation: Farming and fishing
	Race: Not specified
	Education: Maternal education, completed years (mean)
	IFA: 3.9
	LNS: 4.1
	Family income: Not specified
	Inclusion criteria:
	Pregnant women who came for antenatal care at any of the study clinics during the enrolment period and met the following inclusion criteria: ultrasound confirmed pregnancy of no more than 20 completed gestational weeks, residence in the defined catchment area, availability during the period of the study and signed or thumb‐printed informed consent
	Exclusion criteria:
	Age younger than 15 years, need for frequent medical attention due to a chronic health condition, diagnosed asthma treated with regular medication, severe illness warranting hospital referral, history of allergy toward peanuts, history of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care, pregnancy complications evident at enrolment visit (moderate to severe edema, blood haemoglobin concentration <50 g/L, systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg), earlier participation in the iLiNS‐DYAD‐M trial (during a previous pregnancy) or concurrent participation in any other clinical trial
Interventions	Intervention (sample size):
	LNS: Tailor‐made SQ‐LNS from enrolment to 6 months postpartum. Daily dose of 20 g to provide the same micronutrients as MMN, 4 additional minerals (calcium, phosphorus, potassium, magnesium), protein and fat providing 118 kcal of energy. Raw ingredients for LNS included soybean oil, dried skimmed milk, peanut paste, mineral and vitamin mix, and sugar. Intervention was delivered through data collectors (n = 462)
	Control (sample size):
	IFA: received standard antenatal care including supplementation of iron 60 mg, folic acid 400 µg from enrolment to delivery. It was delivered through data collectors (n = 463)
	Concomitant interventions:
	Received intermittent preventive malaria treatment, that is, 2 doses of intermittent preventive malaria treatment with sulphadoxine‐pyrimethamine (3 tablets of 500 mg sulphadoxine and 25 mg pyrimethamine orally). One sulphadoxine‐pyrimethamine dose was given at enrolment and the other between weeks 28 and 34 of gestation
	Health facility nurses gave pretest HIV counselling and tested for HIV infection in all participants, except those who opted out or were already known to be HIV infected, by using a whole‐blood antibody rapid test. LNS (n = 462)
	Training:
	Study physicians trained health providers at all the known private and public health facilities in the area to identify the study participants from their iLiNS identification cards and to record information on any nonscheduled visits on structured data collection forms that were collected and reviewed by the study team on a weekly basis
	Follow‐up:
	Study coordinators invited the participants for follow‐up at the study clinic twice during pregnancy (at 32 and 36 gestational weeks) and once after birth, at 1–2 weeks after delivery and at 6 months; post‐natal follow‐up done till 6 weeks after delivery
	Participants were also provided with mobile phones and airtime so that they could immediately inform the study coordinators about the deliveries (which took place outside the clinics). Upon notification the coordinator visited the site of delivery for interview and infant measurements
Outcomes	Primary outcomes:
	Perinatal mortality
	Neonatal mortality
	Infant mortality
	Secondary outcomes:
	Matenal mortality
	Low birthweight
	Preterm birth
	Small‐for‐gestational age
	Birth weight
	Birth length
	Stunting
	Underweight
	Timing of outcome assessment: Within 6 weeks of birth
Notes	Study start date: February 2011
	Study end date: August 2012
	Time period: 28 months
	Study country: Malawi
	Study limitations:
	Large number of missing data, delays in anthropometric measurements of some participants, temporary discontinuation of LNS distribution and inability to observe consumption of study supplements. However, the smaller sample size than originally intended (due to budget reduction) limited the statistical power of the study. In preliminary analyses from the current study population, maternal malaria, HIV infection, and inflammatory response appeared associated with adverse pregnancy outcomes and also seemed to modify some of the intervention effects on them
	Funding source:
	Supported in part by a grant to the University of California, Davis, from the Bill & Melinda Gates Foundation, with additional funding from the Office of Health, Infectious Diseases, and Nutrition, Bureau for Global Health, US Agency for International Development (USAID) under terms of Cooperative Agreement No. AID‐OAA‐A‐12‐00005, through the Food and Nutrition Technical Assistance III Project (FANTA), managed by FHI 360. For data management and statistical analysis, the team received additional support in grants from the Academy of Finland (grant 252075) and the Medical Research Fund of Tampere University Hospital (grant 9M004). YBC was supported by the Singapore Ministry of Health's National Medical Research Council under its Clinician Scientist Award
	Conflict of Interest: Not specified
	Comments:
	There were 3 arms in the study: LNS (as intervention) and IFA and MMN as control. For our study we took IFA as our control