Randomised, double blind, placebo controlled clinical trial of efficacy of vitamin A treatment in non-measles childhood pneumonia

BMJ
Aug 1997
Citations:64
Influential Citations:3
Interventional (Human) Studies
87
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Methods
Randomised, double blind, placebo-controlled trial at Barão de Lucena Hospital, Recife, Brazil. 472 children aged 6–59 months with clinical pneumonia (259 admitted to hospital; 213 treated as outpatients). Exclusions: xerophthalmia, prior hospitalization for current illness, renal failure, measles, other major infection. Randomisation blocked into groups of four; 239 assigned to vitamin A and 233 to placebo.
Intervention
Vitamin A in oil capsules: 100,000 IU vitamin A and 20 IU vitamin E per capsule. Infants received one capsule on admission and one the next day (total 200,000 IU). Children aged 1–4 years received two capsules on each dosing occasion (admission and the next day), for a total of 400,000 IU. Taken orally in addition to standard pneumonia treatment.
Results
No overall improvement in pneumonia duration or adverse outcomes with high-dose vitamin A. Fever by day 3 was lower in the vitamin A group (16% vs 26.4%; P=0.008). The need to change the first-line antibiotic was lower in the vitamin A group (18% vs 25%; rate ratio 0.71; 95% CI 0.50–1.01; P=0.054). Median duration of pneumonia was 7.6 days with vitamin A vs 7.5 days with placebo. Death and other complications were similar between groups. Conclusion: There is little evidence that high-dose vitamin A improves immediate pneumonia outcomes; routine addition to treatment protocols for childhood pneumonia in areas with marginal vitamin A deficiency is not recommended; improving vitamin A status in deficient populations remains a public health goal.
Limitations
Limited power for etiological subgroup analyses; 26 patients from outside Recife were not followed at home.

Abstract

Abstract Objective: To evaluate the impact on clinical recovery and severity of the addition of large doses of vitamin A to the standard treatment for childhood pneumonia. Design: A randomised, double blind, placebo controlled trial. Setting: Study c...