NCT04012372

ROSA Oligomineral Water for Oral Hydration in 6-Month-Old Healthy Infants

Short-term Safety of ROSA Oligomineral Water in Healthy Serbian Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: University of Novi Sad, Faculty of Sport and Physical Education · Academic / Other
• Sex: All
• Age: 6 Months – 12 Months
• Healthy volunteers: Accepted

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 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.

Conditions

• Hydration

Interventions

Type	Name	Description
OTHER	ROSA Water	Ad libitum hydration with ROSA oligomineral water
OTHER	Control water	Ad libitum hydration with other waters

Timeline

• Start date: 2019-07-20
• Primary completion: 2019-08-31
• Completion: 2019-10-07
• First posted: 2019-07-09
• Last updated: 2019-10-16

Locations

1 site across 1 country: Serbia