NCT04012372

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

July 20, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2019

Completed
Last Updated

October 16, 2019

Status Verified

October 1, 2019

Enrollment Period

1 month

First QC Date

July 4, 2019

Last Update Submit

October 15, 2019

Conditions

Hydration

Keywords

InfantsWaterSafety

Outcome Measures

Primary Outcomes (1)

  • Daily amount of water consumed

    Monitor change in daily amount of water consumed

    Baseline vs. 28-days

Secondary Outcomes (3)

  • Number of stools per day

    Baseline vs. 28-days

  • Body weight

    Baseline vs. 28-days

  • Hydration status

    Baseline vs. 28-days

Study Arms (2)

ROSA water

EXPERIMENTAL

Ad libitum hydration with ROSA oligomineral water

Other: ROSA Water

Control water

ACTIVE COMPARATOR

Ad libitum hydration with other waters

Other: Control water

Interventions

ROSA WaterOTHER

Ad libitum hydration with ROSA oligomineral water

ROSA water
Control waterOTHER

Ad libitum hydration with other waters

Control water

Eligibility Criteria

Age6 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age 6 to 12 months
  • Healthy children
  • Doubled weight at 6 months
  • Tripled weight at 12 months
  • Feed with breast milk of milk formula

You may not qualify if:

  • Any acute or chronic disease
  • Unwillingness to return for follow-up analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dom zdravlja Nis

Niš, Serbia

Location

Related Publications (2)

  • 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.

    PMID: 30506317BACKGROUND

  • Manz F. Hydration in children. J Am Coll Nutr. 2007 Oct;26(5 Suppl):562S-569S. doi: 10.1080/07315724.2007.10719659.

    PMID: 17921466BACKGROUND

Study Officials

  • Milorad Jerkan, MD, PhD

    Dom Zdravlja Nis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2019

First Posted

July 9, 2019

Study Start

July 20, 2019

Primary Completion

August 31, 2019

Study Completion

October 7, 2019

Last Updated

October 16, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)