Abstract
BackgroundDiarrhea causes an estimated 2.5 million child deaths in developing countries each year, 35% of which are due to acute diarrhea. Zinc and copper stores in the body are known to be depleted during acute diarrhea. Our objectives were to evaluate the efficacy of zinc and copper supplementation when given with standard treatment to children with acute watery or bloody diarrhea.MethodsWe conducted a double-blind randomized controlled clinical trial in the Department of Pediatrics at Indira Gandhi Government Medical College Nagpur, India. Eight hundred and eight children aged 6 months to 59 months with acute diarrhea were individually randomized to placebo (Pl), zinc (Zn) only, and zinc and copper (Zn+Cu) together with standard treatment for acute diarrhea.ResultsThe mean duration of diarrhea from enrolment and the mean stool weight during hospital stay were 63.7 hours and 940 grams, respectively, and there were no significant differences in the adjusted means across treatment groups. Similarly, the adjusted means of the amount of oral rehydration solution or intravenous fluids used, the proportion of participants with diarrhea more than 7 days from onset, and the severity of diarrhea indicated by more than three episodes of some dehydration or any episode of severe dehydration after enrolment, did not differ across the three groups.ConclusionThe expected beneficial effects of zinc supplementation for acute diarrhea were not observed. Therapeutic Zn or Zn and Cu supplementation may not have a universal beneficial impact on the duration of acute diarrhea in children.Trial registrationThe study was registered as an International Standard Randomized Controlled Trial (ISRCTN85071383).
Highlights
Diarrhea causes an estimated 2.5 million child deaths in developing countries each year, 35% of which are due to acute diarrhea
Imbalance by chance across trial arms was observed in the following baseline characteristics: dehydration status, oral rehydration solution (ORS) received by the child prior to enrolment and serum zinc (Table 1)
The proportion of children discharged after cessation of diarrhea was 91%, 94% and 95% in the Pl, Zn and Zinc and copper (Zn+Cu) groups respectively (Figure 1)
Summary
Diarrhea causes an estimated 2.5 million child deaths in developing countries each year, 35% of which are due to acute diarrhea. Zinc and copper stores in the body are known to be depleted during acute diarrhea. Our objectives were to evaluate the efficacy of zinc and copper supplementation when given with standard treatment to children with acute watery or bloody diarrhea. The importance of zinc and copper in the pathophysiology of acute diarrhea is highlighted by the significantly higher daily fecal losses of these elements during acute diarrheal episodes than the fecal losses in unaffected children [2]. A pooled analysis of the impact of zinc supplements added to the treatment regimens for acute diarrhea has reported a beneficial effect of reduction in the duration of diarrhea [4]. A recently published Cochrane review has reported a reduction of the duration of acute diarrhea in the zinc group by 12 hours, but there was significant heterogeneity between the trials examined [4,5]. The current paradigm favors the use of Zn supplementation for treatment of acute diarrhea in children [6]
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