NCT01140074

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
256

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 9, 2010

Completed
22 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 10, 2010

Status Verified

June 1, 2010

Enrollment Period

1.9 years

First QC Date

June 7, 2010

Last Update Submit

June 9, 2010

Conditions

Acute Watery Diarrhoea

Keywords

acute diarrhoea, children

Outcome Measures

Primary Outcomes (1)

  • Period of diarrhea in hours

    The primary endpoint of our study is the time of acute diarrhea

    15 days

Secondary Outcomes (1)

  • number of stools in consequent days

    15 days

Study Arms (2)

Zinc sulfate

EXPERIMENTAL

Children in active treatment group will be given zinc sulfate 10-20 mg per day orally plus probiotics

Drug: Zinc Sulfate

Placebo

PLACEBO COMPARATOR

Children will be given placebo plus probiotics

Drug: Zinc Sulfate

Interventions

Zinc SulfateDRUG

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
PlaceboZinc sulfate

Eligibility Criteria

Age1 Month - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 1-36 months
  • Acute diarrhea defined as 3 or more watery stools per day
  • Informed consent (parents)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Szpital im Sw Jadwigi w Trzebicy

Trzebnica, 55-100, Poland

Location

Klinika Pediatrii i Chorob Infekcyjnych Akademii Medycznej we Wroclawiu

Wroclaw, 50-345, Poland

Location

Related Publications (4)

  • 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.

    PMID: 20374562BACKGROUND

  • 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.

    PMID: 19068562BACKGROUND

  • 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.

    PMID: 16354711BACKGROUND

  • 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.

    PMID: 9370894RESULT

MeSH Terms

Interventions

Zinc Sulfate

Intervention Hierarchy (Ancestors)

SulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsInorganic ChemicalsZinc Compounds

Study Officials

  • Leszek Szenborn, Prof

    Wroclaw Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leszek Szenborn, Prof

CONTACT

++48717703151szenborn@zak.am.wroc.pl

Ernest P. Kuchar, MD

CONTACT

++48717703156kuchar@zak.am.wroc.pl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 7, 2010

First Posted

June 9, 2010

Study Start

July 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 10, 2010

Record last verified: 2010-06

Locations

PL(2)