Measurement of Docosahexaenoic Acid Levels in Pre-school ChildrenNCT01897948
The Effects of Feeding Different Levels of Docosahexaenoic Acid to Pre-School Children
A study testing Milk-based beverage without DHA, Milk-based beverage with DHA at mid level and Milk-based beverage with DHA at high level in people with Measurement of Docosahexaenoic Acid Levels in Pre-school Children, run by Mead Johnson Nutrition at 1 site in United States.
Trial summary
This clinical trial will measure Docosahexaenic Acid (DHA) levels in the blood and evaluate the relation to cognitive outcomes. Read more about this study
- Who is it for?
- Ages 3 to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Measurement of Docosahexaenoic Acid Levels in Pre-school Children
- What is being tested?
- Milk-based beverage without DHA, Milk-based beverage with DHA at mid level and Milk-based beverage with DHA at high level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Mar 2014
- 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 3 to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child is 3 years of age ± 90 days
- Weight for length is within 10th to 90th percentile as plotted on WHO growth charts
- Parent/caregiver reports that child consumes at least 6 oz of cow milk or cow milk-based beverages on a daily basis
- Parent is willing to exclude sources of DHA from child's diet during the study
- Parent agrees not to give vitamins to child during the study
- English is the primary language in the home
- Signed Informed Consent and Protected Health Information
Who cannot join
- Gestational age at birth ≤ 36 weeks
- History of neuro/psychiatric conditions
- History of underlying metabolic or chronic disease
- Child is ill, has used antihistamines or diagnosed with an infection at time of cognitive testing
- History of suspected or known cow milk protein intolerance
- Child's diet contains sources of supplemental DHA more than one time per week
Show all 9Show fewer
- Child is from a multiple birth and the sibling(s) are living in the same household
- Child is enrolled in another interventional clinical research study
- Use of antihistamines within 12 hours of cognitive testing
Trial locations and contacts
1 site in 1 country.
United States1 site
Universty of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
This clinical trial will measure Docosahexaenic Acid (DHA) levels in the blood and evaluate the relation to cognitive outcomes.
- Being tested
- Milk-based beverage without DHA, Milk-based beverage with DHA at mid level, Milk-based beverage with DHA at high level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk-based beverage without DHAOther
Milk-based beverage with DHA at mid levelOther
Milk-based beverage with DHA at high levelOther
| Study group | Role | What they receive |
|---|---|---|
| Milk-based beverage with DHA at mid-level | Experimental | Not described Receives: Other: Milk-based beverage with DHA at mid level |
| Milk-based beverage with DHA at high level | Experimental | Not described Receives: Other: Milk-based beverage with DHA at high level |
| Milk-based beverage without DHA | Active comparator | Not described Receives: Other: Milk-based beverage without DHA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red Blood Cell phospholipid weight percent of Docosahexaenoic Acid
Measured: 6 months
Cognitive Measures - Executive Function, Language Development, and Behavior Assessment
Measured: 6 months
Secondary outcomes (9)
Fatty Acid Desaturase (FADS) genotypes
Measured: Once
Plasma Vitamin D levels
Measured: 6 months
Iron levels in the blood
Measured: 6 months
Blood Pressure
Measured: 6 months
Heart Rate
Measured: 6 months
Height and Weight
Measured: 6 months
Recall of dietary intake at each study visit
Measured: 6 months
Parental Product Assessment Questionnaire completed at Study Visit 2
Measured: once
Medically-confirmed adverse events collected throughout the study period
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Non-compliance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Measurement of Docosahexaenoic Acid Levels in Pre-school ChildrenStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Kansas, John Colombo, PhD, The University of Kansas
- Responsible party
- Sponsor
- Investigators
- Carol Lynn Berseth, M.D., Study director, Mead Johnson Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897948
- Sponsor's protocol ID
- 6022
- Status last verified
- Apr 2014
- First submitted
- 3 Jul 2013
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Feeding Different Levels of Docosahexaenoic Acid to Pre-School Children
- ClinicalTrials.gov ID
- NCT01897948
- Acronym / sponsor ID
- 6022
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Non-compliance
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Collaborators
- University of Kansas, John Colombo, PhD, The University of Kansas
- Study start
- Jul 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 12 Jul 2013 (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 clinical trial will measure Docosahexaenic Acid (DHA) levels in the blood and evaluate the relation to cognitive outcomes.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Milk-based beverage with DHA at mid-level | Experimental | Other: Milk-based beverage with DHA at mid level |
| Milk-based beverage with DHA at high level | Experimental | Other: Milk-based beverage with DHA at high level |
| Milk-based beverage without DHA | Active comparator | Other: Milk-based beverage without DHA |
Who may qualify
- Ages
- 3 to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Child is 3 years of age ± 90 days
- Weight for length is within 10th to 90th percentile as plotted on WHO growth charts
- Parent/caregiver reports that child consumes at least 6 oz of cow milk or cow milk-based beverages on a daily basis
- Parent is willing to exclude sources of DHA from child's diet during the study
- Parent agrees not to give vitamins to child during the study
Key exclusion criteria (9 listed)
- Gestational age at birth ≤ 36 weeks
- History of neuro/psychiatric conditions
- History of underlying metabolic or chronic disease
- Child is ill, has used antihistamines or diagnosed with an infection at time of cognitive testing
- History of suspected or known cow milk protein intolerance
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 |
|---|---|---|
| Milk-based beverage without DHA | Other | Milk-based beverage without DHA |
| Milk-based beverage with DHA at mid level | Other | Milk-based beverage with DHA at mid-level |
| Milk-based beverage with DHA at high level | Other | Milk-based beverage with DHA at high level |
Primary outcome
Red Blood Cell phospholipid weight percent of Docosahexaenoic Acid
Time frame: 6 months
Cognitive Measures - Executive Function, Language Development, and Behavior Assessment
Time frame: 6 months
9 secondary outcomes
Fatty Acid Desaturase (FADS) genotypes
Time frame: Once
Plasma Vitamin D levels
Time frame: 6 months
Iron levels in the blood
Time frame: 6 months
Blood Pressure
Time frame: 6 months
Heart Rate
Time frame: 6 months
Height and Weight
Time frame: 6 months
Recall of dietary intake at each study visit
Time frame: 6 months
Parental Product Assessment Questionnaire completed at Study Visit 2
Time frame: once
Medically-confirmed adverse events collected throughout the study period
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Non-compliance). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
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.
Carol Lynn Berseth, 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 Milk-based beverage without DHA, Milk-based beverage with DHA at mid level and Milk-based beverage with DHA at high level in people with Measurement of Docosahexaenoic Acid Levels in Pre-school Children, run by Mead Johnson Nutrition at 1 site in United States.
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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 7 Apr 2014. 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 United States. 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 was stopped early (reason given: Non-compliance). Results are not available in the source record.
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?
Red Blood Cell phospholipid weight percent of Docosahexaenoic Acid (time frame: 6 months). The study lists 2 primary outcomes in all. 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 7 Apr 2014.