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. 2019 Jun 17;2019(6):CD011695. doi: 10.1002/14651858.CD011695.pub2

Radhakrishna 2013.

Methods RCT
Sample size: 324 infants
Inclusion criteria: term healthy infants who would stay in the study area until the child attained 2 years of age
Exclusion criteria: preterm deliveries (gestational age < 37 weeks), LBW (< 2500 g) and infants with congenital abnormalities (neural tube defects, congenital heart disease, cleft palate, and cleft lip) or birth asphyxia
Participants Infants
Age: birth
Country: India
Setting: low‐income urban communities (population of around 25,000 located in the Secunderabad city of the South India)
Interventions Type: zinc supplementation in infants aged 4–18 months. Mothers were counselled on strategies to overcome problems with supplement adherence. Clinic conducted at community centre for study children and treat illnesses (respiratory tract infections, dysentery). Every month, the project staff, responsible for distributing the supplements in the field, collected empty bottles, and provided fresh supplements as per participant identification number and codes.
Urban specificity: none
Level of factors tackled: individual, service delivery, community
Delivery: community groups, service delivery stakeholders, city, and regional governance
Duration (years): 1.2
Comparison:
IG: zinc 5 mg + riboflavin 0.5 mg/day
CG: riboflavin 0.5 mg/day
Measurement: weight and length measured at enrolment and again after 3 and 6 months
PROGRESS at baseline: maternal age, father's age, number of family members, number of antenatal visits
Outcomes Length, HFA, weight at 18 months, WFH, skinfold thickness (triceps, sub scapular)
Notes Funding: no information provided
Impact of the intervention:
IG: HFA at 18 months 61.6%, 21 months 39%, 24 months 29.5%; WFH at 18 months 6.5%, 21 months 11.8%, 24 months 14.3%
CG: HFA at 18 months 61.9%, 21 months 25.1%, 24 months 25.2%; WFH at 18 months 10.1%, 21 months 19.1%, 24 months 24.6%
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random sequence generation was computer‐generated and administered by a separate scientist to the study team.
Allocation concealment (selection bias) Low risk Intervention was concealed
Quote: "The zinc and placebo were prepared and supplied by Biological Evans Limited, in a syrup base, which were of similar colour, consistency and flavour; in two sets of identical looking bottles, labelled 1 and 2."
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk There was a robust system for minimising performance bias.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk There was a robust system for minimising detection bias (see text under 'Blinding of participants and personnel (performance bias)' for evidence).
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk There was a reasonably low rate of attrition (163 infants began in the IG and 9 were lost to follow‐up; 161 began in the CG and 13 were lost to follow‐up) and so it is unlikely to have had great effect on the results. Nevertheless, there was no intention‐to‐treat analysis so it was not possible to fully assess the effect of the attrition.
Selective reporting (reporting bias) Low risk The study protocol identified the primary outcomes to be reported upon; these were reported in the paper.
Other bias Unclear risk None identified. Unclear if the participants benefited from other ongoing interventions during the study period.
Similarity of outcome measures at baseline Low risk No statistically significant difference in the outcome measures at baseline.
Similarity of baseline characteristics Low risk No statistically significant difference in the characteristics between the CG and IG.
Protection against contamination Low risk Community‐based supplementation study where mothers were given bottles to administer at home. Risk of mother sharing bottles was low.