A Phase 2 interventional study of Zinc Sulfate in Acute Watery Diarrhoea, sponsored by University Hospital No 1 Wroclaw. Status unknown at 2 sites in Poland. Open to participants aged 1 Month to 36 Months. Per ClinicalTrials.gov, last updated 2010-06-10.
Sponsored by University Hospital No 1 Wroclaw · Phase 2, Interventional, and Treatment
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.
A double-blind, placebo controlled trial
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
852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.
This study's planned enrollment of 256 is above the median of 136 across 713 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →This is the only study on the registry with University Hospital No 1 Wroclaw as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Children in active treatment group will be given zinc sulfate 10-20 mg per day orally plus probiotics
Drug: Zinc Sulfate
Children will be given placebo plus probiotics
Drug: Zinc Sulfate
Zinc Sulfate in sugar sirup will be given orally in dosis of 10-20 mg per day for 10 days
Also known as: brand product is not available in Poland
Period of diarrhea in hours
The primary endpoint of our study is the time of acute diarrhea
Time frame: 15 days
number of stools in consequent days
The secondary end points will be number of stools per day, necessity of hospitalization or not, tolerability and adherence to the therapy
Time frame: 15 days
This study is status unknown, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.
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