Sharieff 2006a.

Methods	Study design: randomised placebo‐controlled trial Unit and method of allocation: individual Method of sequence generation: computer‐generated random selection of children from each geographical zone Masking of participants, personnel, and outcome assessors: study participants, field staff, and data analyst were blinded
Participants	Location of the study: Bilal Colony, an urban slum neighbourhood in Karachi, Pakistan Sample size: 75 infants Age: 6 to 12 months Sex: 56% boys in micronutrient group, 28% boys in control group Socioeconomic status: similar at baseline between groups (report ethnicity, maternal education, family income, housing structure) Baseline prevalence of anaemia: not reported Baseline prevalence of soil helminths: not reported Baseline malaria prevalence: not reported Inclusion and exclusion criteria: inclusion criteria included intent to reside in the area for 2 or more months, parental consent, and child able to ingest any type of semi‐solid weaning food, 1 or more episode of diarrhoea within previous 2 weeks
Interventions	Participants were randomly assigned to 1 of 3 groups Interventions Group 1* (n = 25): children received daily a micronutrient powder containing 30 mg of elemental iron (as encapsulated ferrous fumarate), 5 mg of zinc (as gluconate), 300 μg of vitamin A, 50 mg of vitamin C, 7.5 μg of vitamin D3, and 150 μg (0.15 mg) of folic acid Group 2 (n = 25): children received daily a micronutrient powder containing 5 mg of zinc (as gluconate), 30 mg of elemental iron (as microencapsulated ferrous fumarate), 50 mg of vitamin C, 300 μg of vitamin A, 7.5 μg of vitamin D3, and 150 μg (0.15 mg) of folic acid and heat‐inactivated Lactobacillis acidophilus at a concentration of 1 to 2 × 10⁹ colony‐forming units (CFUs) per dose Comparison Group 3* (n = 25): children received daily placebo (containing ground purple rice with maltodextrin) Interventions were provided in small screw‐cap plastic containers with powders that were similar in appearance and taste; mothers and caregivers were instructed to open the containers and mix the entire contents with semi‐solid meal provided to the child once each day *For the purposes of this review, only groups 1 and 3 were compared Duration of intervention: 2 months
Outcomes	Primary: longitudinal prevalence of diarrhoea (defined as 3 or more liquid or loose stools in the past 24 hours). Longitudinal prevalence was defined as percentage of days that the child had diarrhoea over the observation period Secondary: febrile days per child, compliance, haemoglobin concentrations, serum ferritin concentrations, anaemia, iron deficiency. Stool cultures at baseline (for Salmonella, Shigella, Campylobacter, Yersinia, enteropathic Escherichia coli and Vibrio cholerae, and Giardia lamblia) Timing of outcome assessment: number of diarrhoeal stools, days of diarrhoea, dysentery, vomiting, presence of fever (and intensity and duration), respiratory symptoms, and drug usage assessed twice a week; blood samples collected at end of 2 months
Notes	Study start date: January 2003 Study end date: March 2003 Conflict(s) of interest: co‐author (S Zlotkin) owns intellectual property rights to micronutrient Sprinkles™ Funding source(s): Canadian Institutes of Health Research, HJ Heinz Foundation, Institut Rosell Lallemand Malaria‐endemic area: yes Comment Compliance was measured by counting the used supplements for each child whose supplements were not shared or lost. 91% of children consumed half of MNP (mean number 36)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: children assigned to treatment via a computer programme
Allocation concealment (selection bias)	Low risk	Comment: study authors provided identical, small screw‐cap plastic containers filled with micronutrients (with or without probiotic) or placebo in powder form, which were similar in appearance and taste
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Comment: study authors provided identical, small screw‐cap plastic containers filled with micronutrients (with or without probiotic) or placebo in powder form, which were similar in appearance and taste. Study participants and field staff were blinded to random allocation
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: data analysts blinded to random allocation
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: 1 child dropped out from the intervention group and 1 from the comparison group
Selective reporting (reporting bias)	Unclear risk	Comment: information insufficient to permit judgement
Other bias	High risk	Comment: haemoglobin and ferritin were not measured at baseline, making it difficult to judge comparability between groups. Only 61% of the original population agreed to provide a blood sample at the end of the study