Methods | RCT Length of follow‐up: 12 months |
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Participants | All children living in endemic area Number analysed for primary outcome: 683 Age range: 2 to 5 years Inclusion criteria: all children aged 2 to 5 in slum area of Tiljala identified and enrolled Exclusion criteria: major illnesses; birth defects; and unwillingness to participate |
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Interventions | Multiple doses vs placebo
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Outcomes |
Other outcomes measured but not reported: stool samples from random sample of 30% (formalin concentration technique) for prevalence of Ascaris; weight‐for‐age; diarrhoeal episodes |
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Notes | Location: India Community category: 2 Source of funding: Indian Council of Medical Research, New Delhi, India. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers sequence. |
Allocation concealment (selection bias) | Low risk | Identical coded bottles. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Participants and key personnel were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 97% (683/702) of enrolled participants were evaluated. Inclusion of all randomized participants (number evaluable/number randomized): 97% (683/702). |
Selective reporting (reporting bias) | High risk | Incomplete reporting of some outcomes (prevalence of Ascaris in stools; weight‐for‐age; diarrhoeal episodes). |
Other bias | Low risk | No obvious other source of bias. |