Methods | RCT Length of follow‐up: 4 months |
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Participants | All children living in endemic area Number analysed for primary outcome: 510 randomized Age range: 6 to 8 years Inclusion criteria: school children aged 6 to 8 years and written informed consent from parents/caregivers Exclusion criteria: haemoglobin concentrations < 80 g/L, chronic illness, congenital abnormalities, mental or severe physical handicap, severe malnutrition ([z‐scores for weight‐for‐height (WHZ) < ‐3.0 SD), obesity (BMI ≥ 25 or z‐scores for WHZ > +2 SD), or receiving deworming within the previous 6 months |
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Interventions | Single dose vs placebo
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Outcomes |
Not included in review: changes in zinc, iodine, and ferritin concentration; worm prevalence Measured but not reported: weight and height recorded at baseline and end point but only baseline data reported. Skin fold thickness recorded at baseline and end point, but no data reported. |
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Notes | Location: Vietnam Community category: 2 This trial was supported by the Neys‐van Hoogstraten Foundation, The Netherlands, and the Ellison Medical Foundation. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated. "pupils were allocated to 1 of the 4 intervention groups based on a computer generated list, matched on age (12‐mo age groups) and sex, and using a block size of 8 by one of the researchers not involved in the field work". |
Allocation concealment (selection bias) | Low risk | Central allocation. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Participants and key personnel were blinded. "All investigators, field assistants, teachers, and children did not know the codes of the trial groups". Placebo identical to treatment (orange chewable tablet). |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 482/510 randomized participants were evaluated. Reasons for drop‐out: moved (n =12), surgery (n = 2), refusal to participate (n = 14), balanced across intervention groups. Inclusion of all randomized participants (number evaluable/number randomized): 94.5% (482/510). |
Selective reporting (reporting bias) | High risk | Three outcomes (weight, height and skin fold thickness) not reported adequately. |
Other bias | Low risk | No obvious other source of bias. |