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. 2015 Jul 23;2015(7):CD000371. doi: 10.1002/14651858.CD000371.pub6
Methods RCT
Length of follow‐up: 4 months
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
Interventions Single dose vs placebo
  1. Non‐fortified biscuit plus placebo deworming‐treatment (placebo);

  2. Multi‐micronutrient–fortified biscuit plus placebo deworming‐treatment;

  3. Non‐ fortified biscuit plus deworming treatment with albendazole (400 mg);

  4. Multi‐micronutrient–fortified biscuits plus deworming treatment with Albendazole (400 mg).

Outcomes
  1. Haemoglobin;

  2. Mean MUAC;

  3. Cognitive function;

  4. Change in weight‐for‐age (WAZ), height‐for‐age (HAZ), and WHZ, using the EpiInfo program (version 6.0, CDC) and the National Center for Health Statistics/WHO nutritional reference data.


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.
Notes Location: Vietnam
Community category: 2
This trial was supported by the Neys‐van Hoogstraten Foundation, The Netherlands, and the Ellison Medical Foundation.
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.