Original Article
European Journal of Clinical Nutrition (2006) 60, 673–680. doi:10.1038/sj.ejcn.1602368; published online 4 January 2006
Antioxidant vitamins E and C as adjunct therapy of severe acute lower-respiratory infection in infants and young children: a randomized controlled trial
Guarantor: D Mahalanabis.
Contributors: DM was responsible for study design, data analysis and writing the manuscript. MB, DP and SG took part in case management and evaluation, skin antigen tests and data collection, and assisted in writing the manuscript. SS and MAW took part in laboratory tests and interpretation and assisted in the writing of the manuscript. MAK took part in the study design, in establishing and standardizing TBARS procedures and interpreting the results, and in writing the manuscript.
D Mahalanabis1, M Basak2, D Paul2, S Gupta1, S Shaikh1, M A Wahed3 and M A Khaled4
- 1Society for Applied Studies, Kolkata, WB, India
- 2BC Roy Memorial Hospital for Children, Kolkata, WB, India
- 3ICDDR-B, Dhaka, Bangladesh
- 4University of Alabama at Birmingham, USA
Correspondence: Dr D Mahalanabis, Society for Applied Studies, 108, Manicktala Main Road, Flat-3/21, Kolkata 700054, WB, India. E-mail: dmahalanabis@vsnl.com
Received 30 November 2004; Revised 31 October 2005; Accepted 4 November 2005; Published online 4 January 2006.
Abstract
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 
-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 -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.
Keywords:
pneumonia in infants, oxidative stress, antioxidant vitamins, treatment, vitamin E, vitamin C
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