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

Hydration Clinical Trial

— ROSAH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04012372
• Other study ID #: 01-CC2019
• Status: Completed
• Phase: N/A
• Start date: July 20, 2019
• Est. completion date: October 7, 2019

Study information

• Verified date: October 2019
• Source: University of Novi Sad, Faculty of Sport and Physical Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 7, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Hydration

Intervention

Other:
• ROSA Water
Ad libitum hydration with ROSA oligomineral water
• Control water
Ad libitum hydration with other waters

Locations

Country	Name	City	State
Serbia	Dom zdravlja Nis	Niš

Sponsors (2)

Lead Sponsor	Collaborator
University of Novi Sad, Faculty of Sport and Physical Education	Dom Zdravlja Nis

Country where clinical trial is conducted

Serbia, 

References & Publications (2)

Manz F. Hydration in children. J Am Coll Nutr. 2007 Oct;26(5 Suppl):562S-569S. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily amount of water consumed	Monitor change in daily amount of water consumed	Baseline vs. 28-days
Secondary	Number of stools per day	Monitor change in number of stools per day	Baseline vs. 28-days
Secondary	Body weight	Monitor change in body weight	Baseline vs. 28-days
Secondary	Hydration status	Monitor clinican-reported change in hydration status	Baseline vs. 28-days