Clinical trial NCT04012372: ROSA Oligomineral Water for Oral Hydration in 6-Month-Old Healthy Infants
Official title: Short-term Safety of ROSA Oligomineral Water in Healthy Serbian Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydration
Keywords: Infants
Water
Safety
Lead sponsor: University of Novi Sad, Faculty of Sport and Physical Education
Sponsor class: OTHER
Collaborators: name: Dom Zdravlja Nis
First posted: 2019-07-09
Enrollment: 65
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Daily amount of water consumed
timeFrame: Baseline vs. 28-days
Secondary outcomes:
measure: Number of stools per day
timeFrame: Baseline vs. 28-days
measure: Body weight
timeFrame: Baseline vs. 28-days
measure: Hydration status
timeFrame: Baseline vs. 28-days
Other outcomes:
Locations:
city: Niš
country: Serbia
facility: Dom zdravlja Nis
Study officials:
affiliation: Dom Zdravlja Nis
name: Milorad Jerkan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Manz F. Hydration in children. J Am Coll Nutr. 2007 Oct;26(5 Suppl):562S-569S. doi: 10.1080/07315724.2007.10719659.