OBJECTIVE: To evaluate the effect of antioxidant Vitamins E and C as adjunct therapy of severe acute lower respiratory infection (ALRI) in children. DESIGN: Randomized double-blind placebo-controlled clinical trial. SETTING:A large childrens' hospital serving the urban poor in Kolkata, India. SUBJECTS:Children aged 2-35 months admitted with severe ALRI. INTERVENTION: In total, 174 children were randomly assigned to receive alpha-tocopherol 200 mg and ascorbic acid 100 mg twice daily or placebo for 5 days. All children received standard treatment for severe ALRI. Outcome measures were: time taken to recover from a very ill status, fever, tachypnoea, and feeding difficulty; and improvement in oxidative stress and immune response indicated by thiobarbituric acid reacting substances (TBARS) and response to skin antigens, respectively. RESULTS:Recovery rate ratios (95% CI) using proportional hazards model were 0.89 (0.64-1.25), 1.01 (0.72-1.41), 0.86 (0.57-1.29), and 1.12 (0.77-1.64) for very ill status, feeding difficulty, fever, and tachypnoea, respectively. TBARS values were high and similar in the two groups at admission, discharge, and at 2 weeks follow-up. Serum alpha-tocopherol significantly increased in treated group at discharge. Immune response to skin antigens were very poor at admission and after 2 weeks, in both groups. CONCLUSION:Infants with severe ALRI failed to benefit from two antioxidant nutrients as adjunct therapy. Severe ALRI in infants may cause cell-mediated immune dysfunction. We need a better understanding of oxidative processes in growing infants to help us better design interventions with antioxidant therapy.
RCT Entities:
OBJECTIVE: To evaluate the effect of antioxidant Vitamins E and C as adjunct therapy of severe acute lower respiratory infection (ALRI) in children. DESIGN: Randomized double-blind placebo-controlled clinical trial. SETTING: A large childrens' hospital serving the urban poor in Kolkata, India. SUBJECTS:Children aged 2-35 months admitted with severe ALRI. INTERVENTION: In total, 174 children were randomly assigned to receive alpha-tocopherol 200 mg and ascorbic acid 100 mg twice daily or placebo for 5 days. All children received standard treatment for severe ALRI. Outcome measures were: time taken to recover from a very ill status, fever, tachypnoea, and feeding difficulty; and improvement in oxidative stress and immune response indicated by thiobarbituric acid reacting substances (TBARS) and response to skin antigens, respectively. RESULTS: Recovery rate ratios (95% CI) using proportional hazards model were 0.89 (0.64-1.25), 1.01 (0.72-1.41), 0.86 (0.57-1.29), and 1.12 (0.77-1.64) for very ill status, feeding difficulty, fever, and tachypnoea, respectively. TBARS values were high and similar in the two groups at admission, discharge, and at 2 weeks follow-up. Serum alpha-tocopherol significantly increased in treated group at discharge. Immune response to skin antigens were very poor at admission and after 2 weeks, in both groups. CONCLUSION:Infants with severe ALRI failed to benefit from two antioxidant nutrients as adjunct therapy. Severe ALRI in infants may cause cell-mediated immune dysfunction. We need a better understanding of oxidative processes in growing infants to help us better design interventions with antioxidant therapy.