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

Abstract

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.

PIP: During October 1991 to March 1993, in Guatemala, clinical researchers conducted a randomized, double-blind, placebo-controlled clinical trial of 263 pediatric patients aged 3-48 months at the Hospital Roosevelt and the Guatemalteco Social Security Institute Hospital, both in Guatemala City. They aimed to determine the efficacy of a high dose of vitamin A (100,000 IU for children under 1 year of age and 200,000 IU for older children) as adjuvant treatment for radiographically confirmed cases of non-measles-related acute lower respiratory tract infection (ALRI). All the children received standard treatment for ALRI (antibiotics, oxygen, bronchodilators, and intravenously administered solutions). 132 children also received vitamin A and 131 received a placebo. Clinicians evaluated the childrens' condition every 8 hours. The two groups were essentially the same in duration of hospitalization; the rate of normalization in the respiratory rate, oxygen saturation, temperature, and clinical score; and adverse outcomes (mechanical ventilation, prolonged hospitalization, readmission or transfer, and death). These findings indicate that high doses of vitamin A in addition to standard treatment for non-measles-related ALRI lack efficacy for the current ALRI episode.