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. 2015 Jul 23;2015(7):CD000371. doi: 10.1002/14651858.CD000371.pub6
Methods RCT
Length of follow‐up: 12 months
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
Interventions Multiple doses vs placebo
  1. Albendazole: 400 mg in a vitamin B complex base liquid; repeated at 6 months;

  2. Placebo: vitamin B complex base.

Outcomes
  1. Mean weight post‐treatment (presented graphically).


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
Notes Location: India
Community category: 2
Source of funding: Indian Council of Medical Research, New Delhi, India.
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.