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Trial registered on ANZCTR


Registration number
ACTRN12614000028606
Ethics application status
Approved
Date submitted
18/12/2013
Date registered
9/01/2014
Date last updated
9/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of a gel hypotonic oral rehydration solution in children with acute diarrhea
Scientific title
A randomised controlled trial evaluating the efficacy of new hypotonic oral rehydration solution containing Zinc (Zn2+) in gel to reduce diarrhea severity and duration in children with acute diarrhea
Secondary ID [1] 283802 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute gastroenteritis 290779 0
dehydration 290861 0
Condition category
Condition code
Oral and Gastrointestinal 291143 291143 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 291144 291144 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
New hypotonic super-oral rehydration solution containing Zinc2+(Zn2+) in gel formulation, it is used to replace fluid and electrolyte losses caused by diarrhea in children with mild to moderate dehydration.
The solution contains:
Sodium 45mmol/L
Potassium 20mmol/L
Chlorine 40mmol/L
Glucose 80mmol/L
Citrate 10mmol/L
Zinc 1mmol/L
The recommended dosage is over 10ml/kg/day, every 4 hours until cessation of symptoms. The follow up was conducted for 72 hours .
Intervention code [1] 288485 0
Treatment: Other
Comparator / control treatment
Standard oral rehydration therapy is the treatment of choice to replace fluid and electrolyte losses caused by diarrhea in children with mild to moderate dehydration. The solution contains:
Sodium 60mmol/L
Potassium 20mmol/L
Chlorine 37mmol/L
Glucose 90mmol/L
Citrate 14mmol/L
The recommended dosage is over 10ml/kg/day, every 4 hours until cessation of symptoms. The follow up was conducted for 72 hours .
Control group
Active

Outcomes
Primary outcome [1] 291133 0
Assess the rate of oral rehydration solution intake in the first 4 and 24 hours by children with acute gastroenteritis. The parents of enrolled children were instructed to record on a specific form: amount of ORS consumed by the child in the first 4 and 24 hours
Timepoint [1] 291133 0
At first 4 and 24 hours of gastroenteritis
Secondary outcome [1] 306097 0
Evaluate the rate of resolution of diarrhea as total diarrhea duration and stool pattern. The parents of enrolled children were instructed to record on a specific form: number and consistency of fecal outputs at 24, 48 and 72 hours; time of the last abnormal (loose or liquid) stools preceding a normal evacuation; occurrence of vomiting or adverse events.
Timepoint [1] 306097 0
At 24 hours, 48 hours and 72 hours from onset of gastroenteritis

Eligibility
Key inclusion criteria
diarrhea lasting less than 24 hours with mild-moderate dehydration
Minimum age
5 Months
Maximum age
36 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
malnutrition; severe dehydration; concomitant severe acute or chronic systemic illness; immunodeficiency; cystic fibrosis; food allergy; chronic gastrointestinal diseases; endocrine diseases; use of pre/pro/symbiotics, antibiotics or any anti-diarrheal medication in the previous 3 weeks.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statistical analysis was performed by a statistician blind to the preparations received by children in the two groups. The Kolmorogov-Smirnov test was performed if continuous variable have a normal distribution. For categorical variables, the Pearson chi-square test or Fisher’s exact test were performed as appropriated. The two groups were compared for continuous variables by t-test for equality of means. Analyses were conducted on an intention-to-treat basis (ITT). Patients allocated in each group were considered available for ITT analysis when received at least 2 doses of treatment. All tests of significance were two-sided. A p value of less than 0.05 was considered significant. The statistical analysis was performed using the SPSS software package for Windows (release16.0.0; SPSS Inc., Chicago, IL, USA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5693 0
Italy
State/province [1] 5693 0

Funding & Sponsors
Funding source category [1] 288460 0
University
Name [1] 288460 0
University of Naples “Federico II”
Address [1] 288460 0
Via S. Pansini 5 80131 Naples, Italy
Country [1] 288460 0
Italy
Primary sponsor type
University
Name
University of Naples “Federico II”
Address
Via S. Pansini 5 80131 Naples, Italy
Country
Italy
Secondary sponsor category [1] 287164 0
None
Name [1] 287164 0
Address [1] 287164 0
Country [1] 287164 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290329 0
COMITATO ETICO PER LE ATTIVITA' BIOMEDICHE DELL'UNIVERSITA' DEGLI STUDI FEDERICO II DI NAPOLI
Ethics committee address [1] 290329 0
via Pansini 5
80131 Naples
Ethics committee country [1] 290329 0
Italy
Date submitted for ethics approval [1] 290329 0
22/09/2010
Approval date [1] 290329 0
18/01/2011
Ethics approval number [1] 290329 0
184/08

Summary
Brief summary
All children aged 5 to 36 months observed in pediatrician offices for diarrhea lasting less than 24 hours with mild-moderate dehydration were considered eligible for the study. the patients were randomly allocated to: Group 1 receiving standard hypotonic oral rehydration solution; or to Group 2 receiving a hypotonic super-oral rehydration solution containing zinc2+ in gel formulation. The parents of enrolled children were instructed to record on a specific form: (a) amount of oral rehydration solution consumed by the child in the first 4 and 24 hours; (b) number and consistency of fecal outputs at 24, 48 and 72 hours; (c) time of the last abnormal (loose or liquid) stools preceding a normal evacuation; (d) occurrence of vomiting or adverse events.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45114 0
Prof Roberto Berni Canani
Address 45114 0
Department of Translational Medical Science and European Laboratory for the Investigation of Food Induced Diseases, University of Naples "Federico II".
Via S. Pansini 5 80131 Naples, Italy
Country 45114 0
Italy
Phone 45114 0
+390817462680
Fax 45114 0
Email 45114 0
berni@unina.it
Contact person for public queries
Name 45115 0
Prof Roberto Berni Canani
Address 45115 0
Department of Translational Medical Science and European Laboratory for the Investigation of Food Induced Diseases, University of Naples "Federico II".
Via S. Pansini 5 80131 Naples, Italy
Country 45115 0
Italy
Phone 45115 0
+390817462680
Fax 45115 0
Email 45115 0
berni@unina.it
Contact person for scientific queries
Name 45116 0
Prof Roberto Berni Canani
Address 45116 0
Department of Translational Medical Science and European Laboratory for the Investigation of Food Induced Diseases, University of Naples "Federico II".
Via S. Pansini 5 80131 Naples, Italy
Country 45116 0
Italy
Phone 45116 0
+390817462680
Fax 45116 0
Email 45116 0
berni@unina.it

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary