HydrationROSAHNCT04012372
ROSA Oligomineral Water for Oral Hydration in 6-Month-Old Healthy Infants
A study testing ROSA Water in people with Hydration, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
Trial summary
The present study evaluates the safety of ROSA oligomineral water in 6-to-12-month old healthy children. Read more about this study
- Who is it for?
- Ages 6 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Hydration
- What is being tested?
- ROSA Water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSerbia
- Study dates
- 20 Jul 2019to 7 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 6 to 12 months
- Healthy children
- Doubled weight at 6 months
- Tripled weight at 12 months
- Feed with breast milk of milk formula
Who cannot join
- Any acute or chronic disease
- Unwillingness to return for follow-up analysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hydration
- Being tested
- ROSA Water, Control water
- Keywords
- Infants, Water, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROSA WaterOther
Ad libitum hydration with ROSA oligomineral water
Control waterOther
Ad libitum hydration with other waters
| Study group | Role | What they receive |
|---|---|---|
| ROSA water | Experimental | Ad libitum hydration with ROSA oligomineral water Receives: Other: ROSA Water |
| Control water | Active comparator | Ad libitum hydration with other waters Receives: Other: Control water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily amount of water consumed
Monitor change in daily amount of water consumed
Measured: Baseline vs. 28-days
Secondary outcomes (3)
Number of stools per day
Monitor change in number of stools per day
Measured: Baseline vs. 28-days
Body weight
Monitor change in body weight
Measured: Baseline vs. 28-days
Hydration status
Monitor clinican-reported change in hydration status
Measured: Baseline vs. 28-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start20 Jul 2019
- Primary completion31 Aug 2019
- Study completion7 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical Education
- Sponsor type
- University, hospital or other
- Collaborators
- Dom Zdravlja Nis
- Responsible party
- Sponsor
- Investigators
- Milorad Jerkan, MD, PhD, Principal investigator, Dom Zdravlja Nis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012372
- Sponsor's protocol ID
- 01-CC2019
- Acronym
- ROSAH
- Status last verified
- Oct 2019
- First submitted
- 4 Jul 2019
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30506317Manz F. Hydration in children. J Am Coll Nutr. 2007 Oct;26(5 Suppl):562S-569S. doi: 10.1080/07315724.2007.10719659.
PubMed 17921466
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Safety of ROSA Oligomineral Water in Healthy Serbian Infants
- ClinicalTrials.gov ID
- NCT04012372
- Acronym / sponsor ID
- ROSAH / 01-CC2019
- Conditions
- Hydration
- Keywords
- Infants, Water, Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical EducationUniversity, hospital or other
- Collaborators
- Dom Zdravlja Nis
- Study start
- 20 Jul 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 7 Oct 2019 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| ROSA water | Experimental | Other: ROSA WaterAd libitum hydration with ROSA oligomineral water |
| Control water | Active comparator | Other: Control waterAd libitum hydration with other waters |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 6 to 12 months
- Healthy children
- Doubled weight at 6 months
- Tripled weight at 12 months
- Feed with breast milk of milk formula
Key exclusion criteria (2 listed)
- Any acute or chronic disease
- Unwillingness to return for follow-up analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROSA WaterAd libitum hydration with ROSA oligomineral water | Other | ROSA water |
| Control waterAd libitum hydration with other waters | Other | Control water |
Primary outcome
Daily amount of water consumed
Time frame: Baseline vs. 28-days
Monitor change in daily amount of water consumed
3 secondary outcomes
Number of stools per day
Time frame: Baseline vs. 28-days
Body weight
Time frame: Baseline vs. 28-days
Hydration status
Time frame: Baseline vs. 28-days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Background: PubMed 30506317Suh 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.
- Background: PubMed 17921466Manz F. Hydration in children. J Am Coll Nutr. 2007 Oct;26(5 Suppl):562S-569S. doi: 10.1080/07315724.2007.10719659.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milorad Jerkan, MD, PhD principal investigator
Dom Zdravlja Nis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROSA Water in people with Hydration, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily amount of water consumed (time frame: Baseline vs. 28-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04012372, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2019.