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

University of Novi Sad, Faculty of Sport and Physical Education

Status: Completed

Conditions: Hydration

Treatments: Other: Control water; Other: ROSA Water

Study type: Interventional

Funder types: Other

Identifiers

NCT04012372

01-CC2019

Details and patient eligibility

About

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

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 6 to 12 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

ROSA water

Experimental group

Description:

Ad libitum hydration with ROSA oligomineral water

Treatment:

Other: ROSA Water

Control water

Active Comparator group

Description:

Ad libitum hydration with other waters

Treatment:

Other: Control water