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. 2020 Feb 28;2020(2):CD008959. doi: 10.1002/14651858.CD008959.pub3

Young 2018 (C).

Methods Study design: longitudinal cross‐over trial
Unit and method of allocation: health subcentre communities randomly assigned to intervention and control
Method of sequence generation: not reported
Masking of participants, personnel, and outcome assessors: none (open label)
Participants Location of the study: West Champaran, Bihar, India
Sample size: 100 households
Age: 6 to 23 months
Sex: 50% female in health centre 1 and 60% female in health centre 2
Socioeconomic status: not reported
Baseline prevalence of anaemia: not reported
Baseline prevalence of soil helminths: not reported
Baseline malaria prevalence: not reported
Inclusion and exclusion criteria: children aged between 6 and 23 months and not currently taking iron supplements were eligible for inclusion. Exclusion criteria included wasting (mid‐upper arm circumference < 11.5 cm); suspected severe anaemia (through assessment of palmar pallor); history of haemoglobinopathy or repeated blood transfusions; and currently ill with pneumonia, fever, or acute diarrhoea
Interventions Two health centres selected, and within each, 50 households randomly selected
  1. Intervention (n = 50): health centre 1, daily MNP for 1 month, followed by 2‐week washout and cross‐over

  2. Comparison (n = 50): health centre 2, twice weekly iron‐folic acid supplementation for 1 month, followed by 2‐week washout and cross‐over


Duration of intervention: 2.5 months
Outcomes Primary: adherence, acceptability
Secondary: maternal preferences for MNP vs iron folic acid supplements
Timing of outcome assessment: adherence and acceptability assessed by survey at baseline, 1 month after first intervention, and 1 month after second intervention; maternal preferences assessed by semi‐structured intervention at end of month 1 and month 2
Notes Study start date: December 2015
Study end date: April 2016
Conflict(s) of interest: none reported
Funding source(s): Bill and Melinda Gates Foundation
Malaria‐endemic area: yes
Comment
No primary or secondary outcomes reported, so no data included
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: randomised, but random sequence generation not described
Allocation concealment (selection bias) Unclear risk Comment: not mentioned
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comment: not blinded
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Comment: not blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: < 5% loss to follow‐up
Selective reporting (reporting bias) Low risk Comment: no apparent selective reporting
Other bias Unclear risk Comment: information insufficient to permit judgement

CRP: C‐reactive protein.
 DMC: Data Monitoring Committee.
 ECD: early cognitive development.
 EDTA: ethylenediaminetetraacetic acid.
 EHFP: enhanced homestead food production.
 FBCFR: food‐based complementary feeding recommendation.
 FDP: food distribution point.
 Fe: iron.
 HAZ: height‐for‐age z score.
 Hb: haemoglobin.
 HDSS: Health and Demographic Surveillance System.
 HOME: Home Observation for Measurement of the Environment.
 IDA: iron deficiency anaemia.
 IFA: iron and folic acid.
 IYCF: Infant young child feeding
 LNS: lipid‐based nutrition supplement.
 MNP: micronutrient powder.
 MUAC: mid‐upper arm circumference.
 PASW: Predictive Analytics Software.
 PF: phenol formaldehyde resin.
 RBP: retinol binding protein.
 SPSS: Statistical Package for the Social Sciences.
 sTfR: soluble transferrin receptor.
 TfR: transferrin receptor.
 VDCs: village development committees.
 WAZ: weight‐for‐age z score.
 WHZ: weight‐for‐height z score.