Randomized, double-blind, placebo-controlled clinical trial of the efficacy of treatment with zinc or vitamin A in infants and young children with severe acute lower respiratory infection.
BACKGROUND
Acute lower respiratory infection (ALRI) is a leading cause of childhood death. Zinc supplementation prevents ALRI. Vitamin A supplementation reduces childhood mortality, but its benefit concerning ALRI-specific mortality is unproven.


OBJECTIVE
The objective was to evaluate the effect of zinc and vitamin A on the clinical recovery of children with severe ALRI.


METHODS
In a controlled trial with a factorial design, 153 children aged 2-24 mo who were hospitalized with severe ALRI were randomly assigned to receive 10 mg zinc as acetate (twice daily for 5 d) plus vitamin A placebo, 10 000 micro g retinol equivalents vitamin A (twice daily for 4 d) plus zinc placebo, zinc plus vitamin A, or zinc and vitamin A placebos. The main outcome variable was the time for resolution of very ill status; other outcomes were resolution of fever, tachypnea, and feeding difficulty.


RESULTS
Recovery rates from very ill status and from fever in zinc-treated boys were 2.6 times (P = 0.004) and 3 times (P = 0.003) those in non-zinc-treated children; feeding difficulty and tachypnea were not significantly different between groups after an adjusted analysis. Recovery rates were not significantly different between groups on the basis of vitamin A treatment. At discharge, serum zinc was 6.06 micro mol/L higher (P = 0.001) in the zinc-treated children, and serum retinol was 0.387 micro mol/L higher (P = 0.001) in the vitamin A-treated children.


CONCLUSIONS
Zinc treatment significantly reduces duration of fever and very ill status in boys, but not in girls, with severe ALRI. Vitamin A treatment of children with severe ALRI had no significant beneficial effect.
Mahalanabis
Dilip
D
Society for Applied Studies, Kolkata, India.
Lahiri
Madhurima
M
Paul
Dilip
D
Gupta
Susham
S
Gupta
Atul
A
Wahed
Mohammed A
MA
Khaled
Mohammed A
MA
D000208:Acute Disease; D002675:Child, Preschool; D003967:Diarrhea / Q000188:drug therapy; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D005334:Fever / Q000188:drug therapy; D006801:Humans; D007223:Infant; D008297:Male; D010919:Placebos; D012141:Respiratory Tract Infections / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D012720:Severity of Illness Index; D012737:Sex Factors; D012893:Sleep Wake Disorders / Q000188:drug therapy; D013997:Time Factors; D016896:Treatment Outcome; D014801:Vitamin A / Q000627:therapeutic use*; D015032:Zinc / Q000627:therapeutic use*
D010919:Placebos; D014801:Vitamin A; D015032:Zinc