Child Nutrition SciencesNCT02776592
Nutritive Effects of a Cow's Milk Based Formula Fed to Young Children
A study testing Cow's milk-based formula with added nutrients and Cow's milk-based formula in people with Child Nutrition Sciences, run by Mead Johnson Nutrition at 1 site in Brazil.
Trial summary
This study aims to determine if a cow's milk-based formula with added nutrients has an effect on memory, reaction time, strategy or other cognitive development indicators in children 4-5 years of age. Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Nutrition Sciences
- What is being tested?
- Cow's milk-based formula with added nutrients and Cow's milk-based formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jul 2016to 23 Dec 2016
- 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 4 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Health child, 4-5 years of age
- Born as full-term (Gestational age of 37-42 weeks)
- Consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to the baseline visit
- Parents or legal guardian agrees not to feed child any food products or supplements containing probiotics or prebiotics
- Signed informed consent
Who cannot join
- History or known or suspected cow milk protein intolerance
- Child who has received any food product ot supplement containing probiotics or prebiotics (with the exception of yogurt) in the 15 days prior to the baseline visit
- Serious concurrent illness that will interfere in the general management of the child
- History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
- Child's z-score of weight for height at baseline is < -3 according to WHO criteria
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Research Center Fima Lifshitz - Federal University of Bahia
Salvador, Estado de Bahia
About this study
This study aims to determine if a cow's milk-based formula with added nutrients has an effect on memory, reaction time, strategy or other cognitive development indicators in children 4-5 years of age.
Read the detailed description
This study aims to determine if a cow's milk-based formula with added nutrients has an effect on memory, reaction time, strategy or other cognitive development indicators in children 4-5 years of age.
- Conditions
- Child Nutrition Sciences
- Being tested
- Cow's milk-based formula with added nutrients, Cow's milk-based formula
- Keywords
- Healthy Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cow's milk-based formula with added nutrientsOther
Cow's milk-based formulaOther
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | A cow's milk-based formula with added nutrients Receives: Other: Cow's milk-based formula with added nutrients |
| Control | Active comparator | A cow's milk-based formula Receives: Other: Cow's milk-based formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Working Memory Capacity
Recall of variable sequences
Measured: Up to 24 weeks
Secondary outcomes (17)
Change in Motor Response Speeds
Measured: Up to 24 weeks
Change in Mental Response Speeds
Measured: Up to 24 weeks
Change in Retention of Visual Information
Measured: Up to 24 weeks
Change in Manipulation of Visual Information
Measured: Up to 24 weeks
Change in Child Behavior Checklist
Assessment of adaptive function
Measured: Up to 24 weeks
Stool Consistency Assessment
Measured: 24 weeks
Systemic antibiotic Usage
Measured: 24 weeks
Missed days due to illness
Measured: 24 weeks
Body Weight
Measured: 24 weeks
Height
Measured: 24 weeks
Study Product Intake Assessment
Measured: 24 weeks
Complete Blood Count (CBC)
Measured: Up to 24 weeks
Blood Fatty Acids
Measured: Up to 24 weeks
Metabolite Biomarkers
Measured: Up to 24 weeks
Serum Phospholipids
Measured: Up to 24 weeks
Immune Markers
Measured: Up to 24 weeks
Medically-confirmed adverse events
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study start20 Jul 2016
- Primary completion23 Dec 2016
- Study completion23 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Nutrition SciencesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Federal University of Bahia
- Responsible party
- Sponsor
- Investigators
- Jon Vanderhoof, M.D., Study director, Mead Johnson Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776592
- Sponsor's protocol ID
- 6036
- Status last verified
- Mar 2017
- First submitted
- 12 May 2016
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritive Effects of a Cow's Milk Based Formula Fed to Young Children
- ClinicalTrials.gov ID
- NCT02776592
- Acronym / sponsor ID
- 6036
- Conditions
- Child Nutrition Sciences
- Keywords
- Healthy Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Collaborators
- Federal University of Bahia
- Study start
- 20 Jul 2016 (actual)
- Primary completion
- 23 Dec 2016 (actual)
- Study completion
- 23 Dec 2016 (actual)
- First posted
- 18 May 2016 (estimated)
- 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.
This study aims to determine if a cow's milk-based formula with added nutrients has an effect on memory, reaction time, strategy or other cognitive development indicators in children 4-5 years of age.
Detailed description
This study aims to determine if a cow's milk-based formula with added nutrients has an effect on memory, reaction time, strategy or other cognitive development indicators in children 4-5 years of age.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Cow's milk-based formula with added nutrientsA cow's milk-based formula with added nutrients |
| Control | Active comparator | Other: Cow's milk-based formulaA cow's milk-based formula |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Health child, 4-5 years of age
- Born as full-term (Gestational age of 37-42 weeks)
- Consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to the baseline visit
- Parents or legal guardian agrees not to feed child any food products or supplements containing probiotics or prebiotics
- Signed informed consent
Key exclusion criteria (5 listed)
- History or known or suspected cow milk protein intolerance
- Child who has received any food product ot supplement containing probiotics or prebiotics (with the exception of yogurt) in the 15 days prior to the baseline visit
- Serious concurrent illness that will interfere in the general management of the child
- History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
- Child's z-score of weight for height at baseline is < -3 according to WHO criteria
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 |
|---|---|---|
| Cow's milk-based formula with added nutrients | Other | Experimental |
| Cow's milk-based formula | Other | Control |
Primary outcome
Change in Working Memory Capacity
Time frame: Up to 24 weeks
Recall of variable sequences
17 secondary outcomes
Change in Motor Response Speeds
Time frame: Up to 24 weeks
Change in Mental Response Speeds
Time frame: Up to 24 weeks
Change in Retention of Visual Information
Time frame: Up to 24 weeks
Change in Manipulation of Visual Information
Time frame: Up to 24 weeks
Change in Child Behavior Checklist
Time frame: Up to 24 weeks
Stool Consistency Assessment
Time frame: 24 weeks
Systemic antibiotic Usage
Time frame: 24 weeks
Missed days due to illness
Time frame: 24 weeks
Body Weight
Time frame: 24 weeks
Height
Time frame: 24 weeks
Study Product Intake Assessment
Time frame: 24 weeks
Complete Blood Count (CBC)
Time frame: Up to 24 weeks
Blood Fatty Acids
Time frame: Up to 24 weeks
Metabolite Biomarkers
Time frame: Up to 24 weeks
Serum Phospholipids
Time frame: Up to 24 weeks
Immune Markers
Time frame: Up to 24 weeks
Medically-confirmed adverse events
Time frame: 24 weeks
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 Mar 2017.
- 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.
Jon Vanderhoof, M.D. study director
Mead Johnson Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cow's milk-based formula with added nutrients and Cow's milk-based formula in people with Child Nutrition Sciences, run by Mead Johnson Nutrition at 1 site in Brazil.
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 5 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 Mar 2017. 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 Brazil. 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?
Change in Working Memory Capacity (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2017.