Antioxidant vitamins E and C as adjunct therapy of severe acute lower-respiratory infection in infants and young children: a randomized controlled trial.
OBJECTIVE
To evaluate the effect of antioxidant Vitamins E and C as adjunct therapy of severe acute lower respiratory infection (ALRI) in children.


METHODS
Randomized double-blind placebo-controlled clinical trial.


METHODS
A large childrens' hospital serving the urban poor in Kolkata, India.


METHODS
Children aged 2-35 months admitted with severe ALRI.


METHODS
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.


CONCLUSIONS
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.
Mahalanabis
D
D
Society for Applied Studies, Kolkata, WB, India. dmahalanabis@vsnl.com
Basak
M
M
Paul
D
D
Gupta
S
S
Shaikh
S
S
Wahed
M A
MA
Khaled
M A
MA
D000208:Acute Disease; D000975:Antioxidants / Q000378:metabolism / Q000627:therapeutic use*; D001205:Ascorbic Acid / Q000378:metabolism / Q000627:therapeutic use*; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007111:Immunity, Cellular; D007194:India; D007223:Infant; D008297:Male; D010084:Oxidation-Reduction; D018384:Oxidative Stress / Q000187:drug effects; D016016:Proportional Hazards Models; D012141:Respiratory Tract Infections / Q000188:drug therapy*; D012720:Severity of Illness Index; D017392:Thiobarbituric Acid Reactive Substances / Q000032:analysis*; D016896:Treatment Outcome; D014810:Vitamin E / Q000378:metabolism / Q000627:therapeutic use*
D000975:Antioxidants; D017392:Thiobarbituric Acid Reactive Substances; D014810:Vitamin E; D001205:Ascorbic Acid