Lima 2014.
Study characteristics | ||
Methods | Individually randomised trial conducted in Fortaleza, the capital of the Ceara state in northeastern Brazil | |
Participants |
Eligibility: children aged 2 months to 9 years Excluded: children with fever > 38 °C or exclusively breastfed Sample: 79 children; 39 in vitamin A group, 40 in control group. Mean age 43.3 months. 57% boys |
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Interventions |
Experimental group: vitamin A 100,000 IU in form of retinol palmitate for children aged < 12 months and 200,000 IU for children aged > 12 months Control group: vitamin E Supplements given at enrolment, 4 months and 8 months |
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Outcomes | Mean serum retinol levels, growth and adverse reactions to vitamin A | |
Notes | Infant mortality rate in study area was 35/1000 live births. Primary objective of study was to measure the effect of vitamin A on barrier function of gastrointestinal tract. Study concluded that the prevalence of new parasitic infection, especially with Giardia species, was significantly decreased with vitamin A intervention, suggesting an immune regulatory modulation of this nutrient on parasitic intestinal infections. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: 79 children were randomly selected (using computer‐generated random numbers). |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient detail provided to make a judgement. |
Blinding (performance bias and detection bias) Blinding of participants | Low risk | Comment: the parent or guardian of the children, field study team and investigators were blinded to treatment agent. |
Blinding (performance bias and detection bias) Blinding of provider | Low risk | Comment: the parent or guardian of the children, field study team and investigators were blinded to treatment agent |
Blinding (performance bias and detection bias) Blinding of outcome assessor | Low risk | Comment: the parent or guardian of the children, field study team and investigators were blinded to treatment agent. Indication that blinded field study teams assessed outcomes. |
Incomplete outcome data (attrition bias) | Low risk | Comment: after 12‐month follow‐up, 22 children were withdrawn from the study due to: change of address (16), parents or guardians did not co‐operate with the study (5), and had above the median z score for length or height at the time of the study initiation (1). The percentage of participants completing the study at 12 months was 72.2%. |
Selective reporting (reporting bias) | High risk | Comment: the objective of study also included reporting of diarrhoea. Authors had reported the overall incidence of diarrhoea in the whole population but the figures were presented in a way that they could not be used in the meta‐analysis. |
Other bias | Low risk | Comment: no other apparent bias observed. |