Levels of DHA in the BloodNCT01174134
The Effects of Study Products Containing Varying Quantities of Docosahexaenoic Acid (DHA)
A study testing Nutritional beverage in people with Levels of DHA in the Blood, run by Mead Johnson Nutrition at 1 site in United States.
Trial summary
The clinical trial will provide a milk-based drink with constant amounts of nutrients but differing amount of Docosahexaenoic Acid (DHA). Read more about this study
- Who is it for?
- Ages 18 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Levels of DHA in the Blood
- What is being tested?
- Nutritional beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to May 2007
- 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 18 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participant is 18 to 36 months of age
- Participant's current weight and height within the 10th to 90th percentiles
- Parent/caregiver reports that participant consumes milk or a milk-based beverage on a daily basis
- Participant lives at home with parent(s) or other family member(s)
- Signed informed consent and authorization obtained to use and or disclose Protected Health Information (PHI)
Who cannot join
- Participant who is receiving any breast milk at time of randomization
- Participant with an active infection.
- Participant with a history of underlying disease, chronic disease, or congenital malformation which in the opinion of the Investigator is likely to interfere with the evaluation of the participant.
- Known or suspected intolerance to cow's milk protein
- Participant diagnosed with diabetes
- Participant is from a multiple birth and the sibling(s) are still living
- Participant with a sibling that has participated in this study.
Trial locations and contacts
1 site in 1 country.
About this study
The clinical trial will provide a milk-based drink with constant amounts of nutrients but differing amount of Docosahexaenoic Acid (DHA).
- Conditions
- Levels of DHA in the Blood
- Being tested
- Nutritional beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional beverageOther
| Study group | Role | What they receive |
|---|---|---|
| Milk-based beverage w/out DHA | Placebo comparator | Not described Receives: Other: Nutritional beverage |
| Milk-based beverage with DHA | Experimental | Not described Receives: Other: Nutritional beverage |
| Milk-based beverage containing DHA at a higher level | Experimental | Not described Receives: Other: Nutritional beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood lipid levels of Docosahexaenoic Acid (DHA) at enrollment and after two months, assessment of usual DHA intake, and product acceptability and use
Secondary outcomes (3)
Growth
Determination of nutrient status, including iron and vitamin D status
Adverse Events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2010 (estimated)
- Study startJul 2006
- Primary completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Levels of DHA in the BloodStudies 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
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Susan Carlson, Ph.D., Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174134
- Sponsor's protocol ID
- 3375-1
- Status last verified
- Aug 2011
- First submitted
- 30 Jul 2010
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Study Products Containing Varying Quantities of Docosahexaenoic Acid (DHA)
- ClinicalTrials.gov ID
- NCT01174134
- Acronym / sponsor ID
- 3375-1
- Conditions
- Levels of DHA in the Blood
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- May 2007 (actual)
- First posted
- 3 Aug 2010 (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.
The clinical trial will provide a milk-based drink with constant amounts of nutrients but differing amount of Docosahexaenoic Acid (DHA).
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Milk-based beverage w/out DHA | Placebo comparator | Other: Nutritional beverage |
| Milk-based beverage with DHA | Experimental | Other: Nutritional beverage |
| Milk-based beverage containing DHA at a higher level | Experimental | Other: Nutritional beverage |
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Participant is 18 to 36 months of age
- Participant's current weight and height within the 10th to 90th percentiles
- Parent/caregiver reports that participant consumes milk or a milk-based beverage on a daily basis
- Participant lives at home with parent(s) or other family member(s)
- Signed informed consent and authorization obtained to use and or disclose Protected Health Information (PHI)
Key exclusion criteria (7 listed)
- Participant who is receiving any breast milk at time of randomization
- Participant with an active infection.
- Participant with a history of underlying disease, chronic disease, or congenital malformation which in the opinion of the Investigator is likely to interfere with the evaluation of the participant.
- Known or suspected intolerance to cow's milk protein
- Participant diagnosed with diabetes
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 |
|---|---|---|
| Nutritional beverage | Other | Milk-based beverage containing DHA at a higher level, Milk-based beverage w/out DHA, Milk-based beverage with DHA |
Primary outcome
Blood lipid levels of Docosahexaenoic Acid (DHA) at enrollment and after two months, assessment of usual DHA intake, and product acceptability and use
3 secondary outcomes
Growth
Determination of nutrient status, including iron and vitamin D status
Adverse Events
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 2 Sep 2011.
Related trials for Levels of DHA in the Blood
Recruiting
A Clinical Trial to Evaluate the Effects of an Omega-3-containing Supplement on DHA and EPA Levels in the Blood
Omega-3 Deficiency, DHA and EPA Blood Levels
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.
Susan Carlson, Ph.D. principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional beverage in people with Levels of DHA in the Blood, 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 5 inclusion and 7 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 2 Sep 2011. 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. Some participants in this study may receive a placebo. 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?
Blood lipid levels of Docosahexaenoic Acid (DHA) at enrollment and after two months, assessment of usual DHA intake, and product acceptability and use. 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 2 Sep 2011.