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

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

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

Study Overview

• Status: Completed
• Conditions: Hydration
• Intervention / Treatment: Other: ROSA Water; Other: Control water

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Serbia
  • Niš, Serbia
    • Dom zdravlja Nis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 1 year (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ROSA water; Ad libitum hydration with ROSA oligomineral water	Other: ROSA Water; Ad libitum hydration with ROSA oligomineral water
ACTIVE_COMPARATOR: Control water; Ad libitum hydration with other waters	Other: Control water; Ad libitum hydration with other waters

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Novi Sad, Faculty of Sport and Physical Education
• Collaborators: Dom Zdravlja Nis
• Investigators: Principal Investigator: Milorad Jerkan, MD, PhD, Dom zdravlja Nis

Publications and helpful links

General Publications

• Suh H, Kavouras SA. Water intake and hydration state in children. Eur J Nutr. 2019 Mar;58(2):475-496. doi: 10.1007/s00394-018-1869-9. Epub 2018 Nov 30.
• Manz F. Hydration in children. J Am Coll Nutr. 2007 Oct;26(5 Suppl):562S-569S. doi: 10.1080/07315724.2007.10719659.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2019
• Primary Completion (ACTUAL): August 31, 2019
• Study Completion (ACTUAL): October 7, 2019

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: July 4, 2019
• First Posted (ACTUAL): July 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 15, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Safety; Infants; Water
• Other Study ID Numbers: 01-CC2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No