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

Shafiqul A Sarker1, Shamima Sultana1, Mark Pietroni2

  • 1Dhaka Hospital, icddr,b, 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka 1212, Bangladesh.

International Journal of Pediatrics
|October 6, 2015
PubMed

Insights

A bioactive polyphenol supplement in oral rehydration solution (ORS) was safe for children with acute diarrhea. Hematological and clinical chemistry profiles remained within normal ranges, showing no adverse effects from the supplement.

Area of Science:

  • Pediatrics
  • Clinical Nutrition
  • Gastroenterology

Background:

  • Acute diarrhea is a common childhood illness globally.
  • Oral rehydration solution (ORS) is a standard treatment.
  • Dietary supplements may offer adjunctive benefits.

Purpose of the Study:

  • To evaluate the safety and hematological/clinical chemistry effects of a bioactive polyphenol supplement in children with acute diarrhea.
  • To compare outcomes between a supplement group and a placebo group.

Main Methods:

  • Double-blind clinical trial with randomized subjects (N=44 supplement, N=41 placebo).
  • Supplement or placebo administered twice daily in ORS for up to 4 days.
  • Daily zinc (10mg) provided to all subjects.
  • Blood samples collected at baseline and end of study for complete blood count, electrolytes, liver function, and creatinine.

Main Results:

  • No significant adverse changes in hematological or clinical chemistry profiles were observed in the supplement group compared to placebo.
  • Most measured blood factors remained stable or changed similarly between groups.
  • Serum AST (SGOT) in the supplement group approached the upper limit of the normal range but was comparable to the control group.

Conclusions:

  • The bioactive polyphenol dietary supplement is safe for children and infants aged 6 months to 5 years when consumed twice daily for 4 days.
  • The supplement did not cause significant adverse hematological or clinical chemistry alterations in pediatric subjects with acute diarrhea.

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