Safety of a Bioactive Polyphenol Dietary Supplement in Pediatric Subjects with Acute Diarrhoea.

Shafiqul A Sarker,Shamima Sultana,Arthur Dover,Mark Pietroni

doi:10.1155/2015/387159

Abstract

The hematological and clinical chemistry profile for children aged 6 months to 5 years with acute diarrhoea was measured in a double blind clinical trial. Subjects were randomized to the study group (N = 44) given a bioactive polyphenol dietary supplement in oral rehydration solution (ORS) or to the control group (N = 41) given distilled water as a placebo in ORS twice daily for up to 4 days. All subjects received 10 mg zinc daily for the 4 days in the study. Venous blood was collected for complete blood count, electrolytes, liver function, and creatinine upon enrollment (baseline) and at the end of 4 days (end of study); mean values were compared by 95% confidence intervals. Overall, blood factors measured either remained the same over the 4 days or increased or decreased at the same levels between the two groups during the study period. All values were within accepted ranges for paediatric subjects except serum AST (SGOT), where the mean value of the study group approached the upper bound of the range on day 4 but was comparable to the value of the control group. Consumption of this supplement twice daily for 4 days is safe for children and infants.

Highlights

Diarrhoeal diseases remain a major threat to human health globally
A total of 85 paediatric subjects were enrolled in this safety study, with 44 subjects receiving the LifeDrops solution mixed with oral rehydration solution (ORS) and 41 subjects receiving distilled water with ORS
The subjects in both groups were comparable in terms of age, weight, and length of time they had experienced diarrhoea before coming to the clinic

Summary

Introduction

Diarrhoeal diseases remain a major threat to human health globally. In the early 1980s, diarrhoeal diseases accounted for about 4.6 million deaths from around 1 billion episodes of illness in children younger than 5 years each year [1]. A decade later, even without significant change in incidence, the number of deaths attributable to diarrhoeal diseases dropped to 3.3 million per year [2]. This reduction in death was attributed primarily to implementation of Oral Rehydration Therapy (ORT) protocols coordinated by the World Health Organization (WHO). The most recent estimates indicate that the number of deaths had been further reduced to 2.5 million [3] While this downward trend is encouraging, the major burden of diarrhoeal illness is experienced still in the developing world, where children suffer from 6 to 7 episodes per year compared to only one episode for children in developed countries [4]. Factors such as poor water supply and sanitation, lack of education about habits, malnutrition, and HIV-associated immunodeficiency underlie the high incidence of diarrhoeal diseases in the developing nations

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