Long 2006a.
Methods | Factorial design, individually randomised trial conducted in La Magdalena Atlicpac, Mexico | |
Participants |
Eligibility: children aged 6‐15 months were eligible for inclusion in the review. Children who were suffering from diseases causing immunosuppression and any congenital or acquired alteration of the digestive tract that could alter the absorption of micronutrients were excluded. Children who were taking vitamin supplements were also excluded from the study. Sample: 786 children were randomised to 4 intervention groups. Mean age of participants was 9.8 months; proportion of boys in study population was 51.7% |
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Interventions | The 4 intervention groups were as follows:
Interventions were delivered every 2 months for 12 months |
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Outcomes | Diarrhoea and respiratory disease morbidity | |
Notes | We have included data of this factorial design trial in 2 sets. The first data set gives comparisons for vitamin A vs placebo, and the second set includes data for vitamin A + zinc vs zinc only. Data on respiratory morbidity was given with three definitions. We have pooled the data for "cough + difficulty breathing" under the heading of lower respiratory tract infection. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The randomisation sequence was generated by using a random‐number table by project personnel from CENSIA, a division of the Mexican Ministry of Health." |
Allocation concealment (selection bias) | Low risk | Quote: "These solutions were packaged in consecutively numbered, colour‐coded, opaque plastic droplet bottles to ensure that field personnel and the principal investigator were blinded." |
Blinding (performance bias and detection bias) Blinding of Participants | Low risk | Quote: "The vitamin A, zinc, and vitamin A + zinc supplements were prepared by personnel at the National Institute of Nutrition in 5‐mL solutions that were similar in taste and appearance." |
Blinding (performance bias and detection bias) Blinding of provider | Low risk | Quote: "This double‐blind randomised trial . . . These solutions were packaged in consecutively numbered, color‐coded, opaque plastic droplet bottles to ensure that field personnel and the principal investigator were blinded." |
Blinding (performance bias and detection bias) Blinding of outcome assessor | Low risk |
Quote: "This double‐blind randomised trial . . . These solutions were packaged in consecutively numbered, color‐coded, opaque plastic droplet bottles to ensure that field personnel and the principal investigator were blinded." Comment: probably done. |
Incomplete outcome data (attrition bias) | Low risk | Comment: lost to follow‐up data given along with reasons for lost to follow‐up. 93 children were lost to follow‐up or excluded. |
Selective reporting (reporting bias) | Unclear risk | Comment: study protocol not available so cannot assess or make any judgement |
Other bias | Low risk | Comment: this study appears to be free of other bias. |