Efficacy of Zinc Sulfate With Probiotics for the Treatment of Acute Diarrhea in Children

Acute Watery Diarrhoea Clinical Trial

— Zinc  

Official title:

Effectiveness and Efficacy of Zinc With Probiotics for the Treatment of Acute Diarrhea in Young Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01140074
• Other study ID #: KB-501/2009
• Status: Not yet recruiting
• Phase: Phase 2
• First received: June 7, 2010
• Last updated: June 9, 2010
• Start date: July 2010
• Est. completion date: June 2012

Study information

• Verified date: June 2010
• Source: University Hospital No 1 Wroclaw
• Contact: Leszek Szenborn, Prof
• Phone: ++48717703151
• Email: szenborn[@]zak.am.wroc.pl
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 256
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 36 Months

Eligibility

Inclusion Criteria:

• Age 1-36 months

• Acute diarrhea defined as 3 or more watery stools per day

• Informed consent (parents)

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)

• Antibiotic therapy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Watery Diarrhoea
• Diarrhea

Intervention

Drug:
• Zinc Sulfate
Zinc Sulfate in sugar sirup will be given orally in dosis of 10-20 mg per day for 10 days

Locations

Country	Name	City	State
Poland	Szpital im Sw Jadwigi w Trzebicy	Trzebnica
Poland	Klinika Pediatrii i Chorob Infekcyjnych Akademii Medycznej we Wroclawiu	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital No 1 Wroclaw

Country where clinical trial is conducted

Poland, 

References & Publications (4)

Boran P, Tokuc G, Vagas E, Oktem S, Gokduman MK. Impact of zinc supplementation in children with acute diarrhoea in Turkey. Arch Dis Child. 2006 Apr;91(4):296-9. Epub 2005 Dec 14. — View Citation

Fajolu IB, Emokpae A, Oduwole AO, Silva BO, Abidoye RO, Renner JK. Zinc supplementation in children with acute diarrhoea. Nig Q J Hosp Med. 2008 Apr-Jun;18(2):101-3. — View Citation

Larson CP, Nasrin D, Saha A, Chowdhury MI, Qadri F. The added benefit of zinc supplementation after zinc treatment of acute childhood diarrhoea: a randomized, double-blind field trial. Trop Med Int Health. 2010 Jun;15(6):754-61. doi: 10.1111/j.1365-3156.2010.02525.x. Epub 2010 Mar 29. — View Citation

Roy SK, Tomkins AM, Akramuzzaman SM, Behrens RH, Haider R, Mahalanabis D, Fuchs G. Randomised controlled trial of zinc supplementation in malnourished Bangladeshi children with acute diarrhoea. Arch Dis Child. 1997 Sep;77(3):196-200. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Period of diarrhea in hours	The primary endpoint of our study is the time of acute diarrhea	15 days	No
Secondary	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	15 days	Yes