Status:
COMPLETED
ROSA Oligomineral Water for Oral Hydration in 6-Month-Old Healthy Infants
Lead Sponsor:
University of Novi Sad, Faculty of Sport and Physical Education
Collaborating Sponsors:
Dom Zdravlja Nis
Conditions:
Hydration
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief Summary
The present study evaluates the safety of ROSA oligomineral water in 6-to-12-month old healthy children.
Detailed Description
Our study is designed as an open-label case-control interventional study that evaluates the safety of 28-day hydration with ROSA water in healthy infants aged 6-12 months. The participants are apparen...
Eligibility Criteria
Inclusion
- Age 6 to 12 months
- Healthy children
- Doubled weight at 6 months
- Tripled weight at 12 months
- Feed with breast milk of milk formula
Exclusion
- Any acute or chronic disease
- Unwillingness to return for follow-up analysis
Key Trial Info
Start Date :
July 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2019
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04012372
Start Date
July 20 2019
End Date
October 7 2019
Last Update
October 16 2019
Active Locations (1)
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1
Dom zdravlja Nis
Niš, Serbia