Clinical Trial: Efficacy of Zinc Sulfate With Probiotics for the Treatment of Acute Diarrhea in Children
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Effectiveness and Efficacy of Zinc With Probiotics for the Treatment of Acute Diarrhea in Young Children
Brief Summary: Diarrheal disease is one of the major causes of morbidity and mortality in children under five. Disease is treated symptomatically with oral rehydration (ORS) as a basic measure. In children with severe zinc deficiency, diarrhea is common and responds quickly to zinc supplementation. Zinc supplementation may also helpful in diarrheal children without zinc deficiency. Effectiveness of zinc was proven in developing countries but was not in Europe. Objective of our study is to assess whether zinc supplementation given with probiotics and ORS is effective in acute diarrhea in children in Poland.
Detailed Summary:
A double-blind, placebo controlled trial
- We are going to enroll 256 patients (aged > 1 months to 36 months) with acute watery diarrhea defined as 3 d or more watery stools per day lasting not less than 1 day and not longer than 5 days.
Exclusion criteria:
severe dehydration (> 10%) Coexisting severe infection (E.g. Sepsis, pneumonia, meningitis) Immune deficiency Chronic digestive tract disease (e.g. celiac diseases, food allergy) Therapy with Antibiotics
Patients will be randomly assigned to 2 groups to receive: (a) zinc sulfate 10-20 mg/day for 10 days plus probiotics for 5 days (b) placebo for 10 days plus probiotics for 5 days. Patients will be observed in ambulatory or in the hospital (if necessary) and followed up for 15 days.
Randomization 1:1
Sponsor: University Hospital No 1 Wroclaw
Current Primary Outcome: Period of diarrhea in hours [ Time Frame: 15 days ]
Original Primary Outcome: lasting of diarhoea in hours [ Time Frame: 15 days ]
Current Secondary Outcome: number of stools in consequent days [ Time Frame: 15 days ]
Original Secondary Outcome: number of stools in consequent days [ Time Frame: 15 days ]
Information By: University Hospital No 1 Wroclaw
Dates:
Date Received: June 7, 2010
Date Started: July 2010
Date Completion: June 2012
Last Updated: June 9, 2010
Last Verified: June 2010