Methods | RCT Length of follow‐up: 14 months |
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Participants | All children living in endemic area Number analysed for primary outcome: 320 Age range: 12 to 59 months Inclusion criteria: pre‐school children aged 12 to 59 months, either sex Exclusion criteria: severe anaemia < 5 g/dL, severe malaria |
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Interventions | Multiple doses vs placebo
Treatment strategy: 200 mg (one tablet) albendazole was given to children aged 1 year, 400 mg (two tablets) albendazole was given to children aged 2, 3, and 4 years. Children who were in the placebo group were given one or two (1 year) placebo (2 to 4 years) tablets. Treatment or placebo was given at baseline, 4, 8, and 12 months and then followed up for the last time at 14 months. Children in the placebo group were treated with albendazole at 14 months. |
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Outcomes |
Unable to use: nutritional status and anthropometric measures, at baseline and 14 months, no data was reported for these outcomes. Not included in review: infection with STHs, measured at baseline and 4, 8, 12, and 14 months (eggs or worms in stool sample). Incidence of malaria and malaria attacks, measured at baseline and 4, 8, 12, and 14 months. Adverse events not fully reported for albendazole treatment vs placebo. |
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Notes | Location: 4 semi‐urban villages, Osun State, Nigeria Community category: 3 No adverse events reported in the albendazole treatment group. Not reported for control group. Source of funding: Health Research Board (HRB) (Ireland). GlaxoSmithKline sponsored the drug albendazole which was used in the trial. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quasi‐randomized, "During the first assessment each alternate child was assigned tablet B". |
Allocation concealment (selection bias) | High risk | Alternation, one of the investigators "placed the albendazole and placebo tablets in containers labelled either A or B" later "The treatment coordinator [...] oversaw the allocation of treatments to the children". |
Blinding (performance bias and detection bias) All outcomes | Low risk | Participants and key personnel were blinded. "Experienced physicians […] enrolled all participants, measured all trial endpoints, and were kept masked to treatment allocation of children. Field workers involved in data collection and mothers of participating children were also masked to the treatment allocation." "Albendazole and placebo tablets were identical". |
Incomplete outcome data (attrition bias) All outcomes | High risk | 320 children (out of 1228, 26.1%) complied with all the follow‐up assessments and were included in the analyses. Inclusion of all randomized participants (number evaluable/number randomized): 26% (320/1228). |
Selective reporting (reporting bias) | High risk | Nutritional status and anthropometric measures not reported. Main paper states these outcomes are reported in the companion paper; no data reported for these outcomes in the companion paper. |
Other bias | Low risk | No obvious other source of bias. |