Ashorn 2015

Methods	Parallel randomised trial recruiting at 4 sites in Malawi. Setting: 1 public district hospital (Mangochi), 1 semiprivate hospital (Malindi), and 2 public health centres (Lungwena and Namwera) in Mangochi District, southern Malawi.
Participants	Inclusion: ultrasound‐confirmed pregnancy of no more than 20 completed gestation weeks, residence in the defined catchment area, availability during the period of the study, and signed or thumb‐printed informed consent. Exclusion: 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 Hb concentration, 50 g/L, systolic blood pressure .160 mm Hg or diastolic blood pressure .100 mm Hg), earlier participation in the iLiNS‐DYAD‐M trial (during a previous pregnancy), or concurrent participation in any other clinical trial. 1391 women randomised. (IFA – 463; MMN 466; LNS – 462). Lost to follow‐up (IFA 26; MMN 32; LNS 26). Group demographic characteristics similar.
Interventions	Intervention: Group 1: IFA – 1 capsule containing 60 mg iron and 400 mcg folic acid and 2 doses of intermittent preventive malaria treatment with sulfadoxine‐pyrimethamine. Group 2: MMN – malaria treatment as above plus 1 capsule containing IFA and 16 micronutrients. Group 3: LNS – malaria treatment as above and sachets of SQ‐LNS containing the same micronutrients as group 2 plus 4 additional minerals, protein and fat (118 kcal). All supplements to be taken daily. Follow‐up until 6 weeks postpartum. Data collectors delivered supplements fortnightly. Participants were invited to antennal care visits at the clinic at 32 and 36 weeks and 1‐2 weeks postpartum. Participants were given mobile phones and airtime so that they could inform of deliveries outside of clinics.
Outcomes	Primary outcomes: birthweight and newborn length (within 6 weeks of birth). Secondary outcomes: newborn weight, head circumference, mid‐upper arm circumference (MUAC), and the duration of pregnancy, as well as the incidence of maternal or newborn SAEs. Several other maternal and infant outcomes are reported.
Notes	Due to testing of LNS products for a bacteria, 160 pregnant women in the LNS group missed out their supplement for 1‐20 days during August 2012. 127 of these women were provided with IFA tablets at this time, while 33 were not available for contact. Adverse events were recorded separately and monitored, and a study physician determined if the participant should continue with the allocated supplement. Analysis modified ITT = participants with missing data for an outcome were excluded from analysis of that outcome. 12 twin pregnancies were excluded from all analyses. This trial included women with a + HIV test: IFA = 15.6%; MMN 11.1% and LNS 14.4% We have contacted authors to see if separate analyses for HIV‐ women are available. Authors have agreed to provide these data for inclusion in the next update of this review.