Efficacy of Zinc Sulfate With Probiotics for the Treatment of Acute Diarrhea in Children
NCT ID: NCT01140074
Last Updated: 2010-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
256 participants
INTERVENTIONAL
2010-07-31
2012-06-30
Brief Summary
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Detailed Description
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\- 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
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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Zinc sulfate
Children in active treatment group will be given zinc sulfate 10-20 mg per day orally plus probiotics
Zinc Sulfate
Zinc Sulfate in sugar sirup will be given orally in dosis of 10-20 mg per day for 10 days
Placebo
Children will be given placebo plus probiotics
Zinc Sulfate
Zinc Sulfate in sugar sirup will be given orally in dosis of 10-20 mg per day for 10 days
Interventions
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Zinc Sulfate
Zinc Sulfate in sugar sirup will be given orally in dosis of 10-20 mg per day for 10 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Acute diarrhea defined as 3 or more watery stools per day
* Informed consent (parents)
Exclusion Criteria
* Coexisting severe infection (e.g. sepsis, pneumonia, meningitis)
* Immune deficiency
* Chronic digestive tract disease (e.g. celiac diseases, food allergy)
* Antibiotic therapy
1 Month
36 Months
ALL
No
Sponsors
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University Hospital No 1 Wroclaw
OTHER
Responsible Party
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Katedra i Klinka Pediatrii i Chorob Infekcyjnych AM we Wroclawiu
Principal Investigators
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Leszek Szenborn, Prof
Role: PRINCIPAL_INVESTIGATOR
Wroclaw Medical University
Locations
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Szpital im Sw Jadwigi w Trzebicy
Trzebnica, , Poland
Klinika Pediatrii i Chorob Infekcyjnych Akademii Medycznej we Wroclawiu
Wroclaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Jerzy Pejcz, MD
Role: primary
References
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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.
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. doi: 10.4314/nqjhm.v18i2.44997.
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. doi: 10.1136/adc.2005.079939. Epub 2005 Dec 14.
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. doi: 10.1136/adc.77.3.196.
Other Identifiers
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KB-501/2009
Identifier Type: -
Identifier Source: org_study_id
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