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

Study Overview
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Brief Summary
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The present study evaluates the safety of ROSA oligomineral water in 6-to-12-month old healthy children.

Detailed Description
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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.

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

Conditions
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Hydration

Intervention / Treatment
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* Other: ROSA Water
* Other: Control water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: Any acute or chronic disease Unwillingness to return for follow-up analysis

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ROSA water<br>Ad libitum hydration with ROSA oligomineral water | Other: ROSA Water<br>* Ad libitum hydration with ROSA oligomineral water<br>|
| Active Comparator: Control water<br>Ad libitum hydration with other waters | Other: Control water<br>* Ad libitum hydration with other waters<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily amount of water consumed | Monitor change in daily amount of water consumed | Baseline vs. 28-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of stools per day | Monitor change in number of stools per day | Baseline vs. 28-days | 
| Body weight | Monitor change in body weight | Baseline vs. 28-days | 
| Hydration status | Monitor clinican-reported change in hydration status | Baseline vs. 28-days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infants, Water, Safety