Adrianopoli 2014 (C).

Methods	Study design: cluster‐randomised pilot trial Unit and method of allocation: randomisation at village level Method of sequence generation: 2‐stage cluster‐sampling method was used. 20 clusters were selected and randomly assigned to 1 of 2 groups. 30 eligible households were selected from each cluster (n = 20). Method details were not described Masking of participants, personnel, and outcome assessors: not reported
Participants	Location of the study: Tajikistan, Khatlon Province, and Gorno‐Badakhshan Autonomous Region Sample size: 209 Dropouts/withdrawals: 52 dropped out at first follow‐up (3 months), 1 dropped out at second follow‐up (6 months), 11 dropped out at third follow‐up (12 months) Age: 6 to 12 months Sex: both sexes. Male:female ratio = 45:55 in group A, 61:39 in group B Socioeconomic status: not reported Baseline prevalence of anaemia: 100% (moderate anaemia) Baseline prevalence of soil helminths: not reported Baseline malaria prevalence: not reported Inclusion and exclusion criteria: infants and young children (IYC) who were anaemic were the target population for the study. Blood haemoglobin levels and nutritional status were assessed during the screening phase. 209 IYC with a haemoglobin concentration > 7 g/dL and < 11 g/dL and aged 6 to 12 months were included. IYC presenting with severe clinical malnutrition (weight‐for‐height z score, or WHZ, < −3), haemoglobin level < 7 g/dL, severe chronic illness, and congenital abnormalities were excluded. Children receiving iron supplementation or enrolled in a therapeutic feeding programme were also excluded
Interventions	209 IYC were randomly assigned to 1 of the 2 intervention groups Intervention: Group B (n = 105): received FBCFRs (food‐based complementary feeding recommendations) plus MNP (12.5 mg of iron, 5 mg of zinc, 300 μg of vitamin A, 160 μg of folic acid, and 30 mg of vitamin C in powder form, daily) Comparison: Group A (n = 104): received FBCFRs (age‐specific) Duration of intervention: 12 months
Outcomes	Primary: haemoglobin concentrations, iron status, anthropometric measurements (z scores of the index weight‐for‐length), dietary assessment Secondary: morbidity, side effects (episodes of diarrhoea, respiratory illness, severe vomiting, and visits to physicians) Timing of outcome assessment: baseline, first follow‐up (3 months), second follow‐up (6 months), third follow‐up (12 months)
Notes	Study start date: November 2007 Study end date: April 2009 Conflict(s) of interest: not reported Funding source(s): US Centers for Disease Control and Prevention (CDC) Malaria‐endemic area: yes Comments Mothers from group A have been more compliant with the recommendations than mothers from group B. The prevalence of moderate acute malnutrition (WHZ −2 to −3) was 12% in both groups at baseline Both malaria and malnutrition are present in Tajikistan
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "randomly assigned" Comment: method details not described
Allocation concealment (selection bias)	Unclear risk	Comment: not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: not described, but blinding could not be possible due to the nature of the intervention
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: not described and probably not attempted; however, non‐blinding of outcome assessment appears likely to have affected outcome measurements
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: 56% (58/104) in group A and 47% (49/105) in group B completed all 3 follow‐up measurements
Selective reporting (reporting bias)	Unclear risk	Comment: protocol not available
Other bias	Low risk	Comment: appears to be free of other sources of bias