Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Sex
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
9/01/2012
Actual
9/01/2012
Date of last participant enrolment
Anticipated
Actual
14/06/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
80
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”
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
[email protected]
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
[email protected]
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
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAcceptability and efficacy of a gel hypotonic oral rehydration solution in children with acute gastroenteritis.2015https://dx.doi.org/10.1097/MEG.0000000000000320
N.B. These documents automatically identified may not have been verified by the study sponsor.