Home » Trials » SLCTR/2015/012 » Progress Reports
Date Modified
2016-06-19
Period
6/months
Report Summary
Effects of Vitamin E Supplementation on the clinical outcome of Dengue Fever (DF) and Dengue Hemorrhagic Fever (DHF) in Children: A preliminary Report Report up to 30th April 2016 Dengue fever has increased dramatically in recent times with considerable mortality and complications. Oxidative stress is postulated to be a mechanism of tissue injury and antioxidants may have a place in the management. This study aims to evaluate the effects of vitamin E supplementation on the clinical course of DF and DHF in children. Methods A triple-blind controlled trial was conducted at professorial Paediatric Unit at the Lady Ridgway Hospital. Febrile, 5-12 year old children suspected of dengue fever were randomly allocated to receive vitamin E or placebo. Standard ward management for DF/DHF was provided for both groups. Clinical, biochemical (AST, ALT, Serum Albumin/Cholesterol/Calcium) and haematological (WBC, Platelets, PCV) parameters were monitored regularly throughout the course of the illness and diagnosis of dengue infection was confirmed serologically. Result 104 children are recruited up to 30th April 2016. Data were analysed om 82 subjects. The temporal distribution patterns of WBC, platelets, serum albumin, serum cholesterol and serum calcium levels were higher, while PCV, AST and ALT levels were lower in the treatment group compared to placebo. Day 3 platelet count (155 Vs 124, p=0.02), day 3 PCV (38.5 Vs 39.9, p=0.041), day 2.5 cholesterol (4.53 Vs 3.79, p=0.042), calcium on day 4.5 (2.37 Vs 2.24, p=0.047) and day 6 (2.41 Vs 2.28, p=0.02) were significantly improved in the treatment group. There was no difference in the duration of stay or occurrence of leaking however the duration of leaking was significantly lower in the treatment group (30.67 Vs 45.8hours, p=0.02). Results so far has shown that treatment with vitamin E shows a significant improvement in clinical, haematological and biochemical parameters in children with DF and DHF. Execution of the trial The study process of both phases is to be carried out continuously until the required sample size is collected. No changes will be done to the protocol as we have been carrying out the study successfully with the approved protocol. Unforeseen events No adverse effects were noted to the medication while carrying out the trial
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