An interventional study of ROSA Water and Control water in Hydration, sponsored by University of Novi Sad, Faculty of Sport and Physical Education. Completed at 1 site in Serbia. Open to participants aged 6 Months to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-16.
Sponsored by University of Novi Sad, Faculty of Sport and Physical Education · Not applicable, Interventional, and Supportive care
The present study evaluates the safety of ROSA oligomineral water in 6-to-12-month old healthy children.
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 apparently healthy children breastfed or formula fed; minimal sample size (n = 52) was calculated according to 0.8 power to detect a significant difference in the prevalence of diarrhea (G*Power 3.1). Final group of participants will consist of sixty-five healthy male and female infants (we presume that 20% of participants will drop-out throughout the study). The stopping rules for participants include a refuse to participate in this research at any time and significant change of health status. All participants will be allocated in an open-label manner to two randomly assigned ad libitum hydration regimens: first group will receive ROSA water for daily hydration, and second (control) group will receive other water of personal choice (including tap water). All testing including parental diary of infant general status (e.g. daily amount of water consumed, number of stools per day, nutritional habits) and clinician-reported outcomes (e.g. body weight, clinical evaluation of hydration will be conducted at pre-administration (baseline) and at follow-up (after 28 days of administration). The study is entirely voluntary and the participants are free to stop participating at any time.
University of Novi Sad, Faculty of Sport and Physical Education is the lead sponsor of 19 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ad libitum hydration with ROSA oligomineral water
Other: ROSA Water
Ad libitum hydration with other waters
Other: Control water
Ad libitum hydration with ROSA oligomineral water
Ad libitum hydration with other waters
Daily amount of water consumed
Monitor change in daily amount of water consumed
Time frame: Baseline vs. 28-days
Number of stools per day
Monitor change in number of stools per day
Time frame: Baseline vs. 28-days
Body weight
Monitor change in body weight
Time frame: Baseline vs. 28-days
Hydration status
Monitor clinican-reported change in hydration status
Time frame: Baseline vs. 28-days
Plan to share: No
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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University of Novi Sad, Faculty of Sport and Physical Education