Clinical trial of vitamin A as adjuvant treatment for lower respiratory tract infections.

OBJECTIVE

To test the efficacy of a high dose of vitamin A as adjuvant treatment for radiographically confirmed cases of acute lower respiratory tract infection (ALRI).

DESIGN

Randomized, double-masked, placebo-controlled clinical trial.

SETTING

Two large urban hospitals in Guatemala City.

PATIENTS

Sequential sample of 263 children aged 3 to 48 months, identified in the emergency departments and admitted to the hospital.

INTERVENTIONS

Vitamin A (100,000 IU for children less than 1 year of age, and 200,000 IU for older children) or placebo in addition to standard treatment for ALRI which included antibiotics, oxygen, bronchodilators, and intravenously administered solutions.

MEASUREMENTS AND MAIN RESULTS

The children were assessed every 8 hours. There were neither statistically nor clinically significant differences by treatment group in the rate of normalization in respiratory rate, oxygen saturation, temperature, or clinical score. Duration of hospitalization was not different by treatment group. Adverse outcomes (mechanical ventilation, prolonged hospitalization, readmission or transfer, and death) were equally distributed between the two groups.

CONCLUSIONS

Treatment with high doses of vitamin A over and above standard care for infants and children with non-measles-related ALRI is not efficacious for the current episode. Additional trials among populations in which vitamin A deficiency is more prevalent and severe should be considered.