title: The effect of providing lipid-based nutrient supplements on morbidity in rural Malawian infants and young children: a randomized controlled trial.
abstract: Safety of home fortificants in children is uncertain in areas where infections are common. We tested the hypothesis that provision of lipid-based nutrient supplements (LNS) containing Fe does not increase infectious morbidity in children.
  
  
  
  Randomized controlled trial. Infants were randomised to receive 10, 20 or 40 g LNS/d; or no supplement until age 18 months. All LNS contained 6 mg Fe/d. Morbidity outcomes (serious adverse events, non-scheduled visits and guardian-reported morbidity episodes) were compared between control and intervention groups using a non-inferiority margin of 20 %.
  
  
  
  Namwera and Mangochi catchment areas in rural Malawi.
  
  
  
  Infants aged 6 months (n 1932).
  
  
  
  The enrolled 1932 infants contributed 1306 child-years of follow-up. Baseline characteristics were similar across groups. Compared with the control group, the relative risk (95 % CI) of serious adverse events was 0·71 (0·48, 1·07), 0·67 (0·48, 0·95) and 0·91 (0·66, 1·25) in 10, 20 and 40 g LNS/d groups, respectively. The incidence rate ratio (95 % CI) of non-scheduled visits due to malaria was 1·10 (0·88, 1·37), 1·08 (0·89, 1·31) and 1·21 (1·00, 1·46), and of guardian-reported morbidity episodes was 1·04 (0·96, 1·11), 1·03 (0·97, 1·10) and 1·04 (0·97, 1·10), in the respective LNS groups.
  
  
  
  Provision of 10 and 20 g LNS/d containing 6 mg Fe/d did not increase morbidity in the children. Provision of 40 g LNS/d did not affect guardian-reported illness episodes but may have increased malaria-related non-scheduled visits.
authors.affiliation: 1Department for International Health,University of Tampere School of Medicine,Tampere,Finland.
authors.forename: Jaden
authors.initials: J
authors.lastname: Bendabenda
authors.affiliation: 1Department for International Health,University of Tampere School of Medicine,Tampere,Finland.
authors.forename: Lotta
authors.initials: L
authors.lastname: Alho
authors.affiliation: 1Department for International Health,University of Tampere School of Medicine,Tampere,Finland.
authors.forename: Ulla
authors.initials: U
authors.lastname: Ashorn
authors.affiliation: 3Centre for Quantitative Medicine,Duke-National University of Singapore Graduate Medical School,Singapore,Singapore.
authors.forename: Yin Bun
authors.initials: YB
authors.lastname: Cheung
authors.affiliation: 4Department of Nutrition,University of California,Davis,Davis,CA,USA.
authors.forename: Kathryn G
authors.initials: KG
authors.lastname: Dewey
authors.affiliation: 5Department of Agricultural and Resource Economics,University of California,Davis,Davis,CA,USA.
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Vosti
authors.affiliation: 2School of Public Health and Family Medicine,University of Malawi College of Medicine,Postgraduate Building,Mahatma Gandhi Road,Private Bag 360,Blantyre 3,Malawi.
authors.forename: John
authors.initials: J
authors.lastname: Phuka
authors.affiliation: 2School of Public Health and Family Medicine,University of Malawi College of Medicine,Postgraduate Building,Mahatma Gandhi Road,Private Bag 360,Blantyre 3,Malawi.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Maleta
authors.affiliation: 1Department for International Health,University of Tampere School of Medicine,Tampere,Finland.
authors.forename: Per
authors.initials: P
authors.lastname: Ashorn
mesh_terms: D002675:Child, Preschool; D019587:Dietary Supplements; D005260:Female; D006801:Humans; D007223:Infant; D008055:Lipids / Q000008:administration & dosage*; D008295:Malawi; D008297:Male; D009017:Morbidity; D012424:Rural Population
chemical_list: D008055:Lipids
keywords: Children; Infectious disease morbidity; Iron; Lipid-based nutrient supplements; Low-income countries