ChildrenNCT02125123
Oral Nutritional Supplementation in Children
A study testing Nutritional Supplement and Counseling and Counseling in people with Children, run by Abbott Nutrition at 2 sites in United States.
Trial summary
This study will investigate the effect of an oral nutritional supplement (ONS) along with dietary counseling on improving the dietary intake among children with picky eating behaviors. Read more about this study
- Who is it for?
- Ages 36 to 109 monthsHealthy volunteers can take part
- Conditions the study is for
- Children
- What is being tested?
- Nutritional Supplement and Counseling and Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2014to Jul 2015
- 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 36 to 109 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ≥ 36 months and < 109 months of age.
- Healthy and not suffering from any physical disability.
- Height-for-age and BMI-for-age between the 5th and the 95th percentile; weight-for-age between the 5th and the 85th percentile.
- Capable of oral feeding.
- Has a mean score of greater than 3.0 on the fussiness category in the Children's Eating Behaviour Questionnaire and also consumes on average less than the daily recommendations for at least 3 of 5 food groups (Dietary Guidelines for America, 2010).
- Willing to abstain from consuming non-study nutritional supplements during the study intervention period.
Who cannot join
- History of an acute or chronic condition that may affect feeding habits or nutritional status.
- Taking any medications or nutritional supplements on a daily basis for more than 2 weeks during the past month that may profoundly affect feeding habits or nutritional status.
- Clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement.
- Any acute/chronic condition requiring medical treatment which may include hospitalization.
- Allergy or intolerance to any ingredient in the study product.
- Gastrointestinal infection, acute constipation or acute diarrhea.
Show all 10Show fewer
- Hepatitis B or C, or HIV, or malignancy.
- Congenital cardiac defects.
- Dysphagia, aspiration risk or difficulty in swallowing due to acquired/congenital abnormalities.
- Parent(s)/LG of the subject has any clinically significant medical disease or physical/psychological condition that may interfere with protocol adherence or ability of the parent(s)/LG to give informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Radiant Research, Inc.
Cincinnati, Ohio, 45249
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68516
About this study
Official title: Oral Nutritional Supplementation in Children With Picky Eating Behaviors
This study will investigate the effect of an oral nutritional supplement (ONS) along with dietary counseling on improving the dietary intake among children with picky eating behaviors.
- Conditions
- Children
- Being tested
- Nutritional Supplement and Counseling, Counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional Supplement and CounselingOther
Ready-to-feed nutritional supplement and dietary counseling
CounselingOther
Dietary counseling
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Supplement and Counseling | Experimental | Two servings a day; ready-to-feed nutritional supplement plus dietary counseling Receives: Other: Nutritional Supplement and Counseling |
| Counseling | Active comparator | Dietary Counseling Receives: Other: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D Intake
Measured: Change from Baseline to Week 4
Secondary outcomes (2)
Macronutrient Intake
24-hour dietary recall interview
Measured: Change from Baseline to Week 4
Micronutrient Intake
24-hour dietary recall interview
Measured: Change from Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Williams, MPH, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125123
- Sponsor's protocol ID
- AL15
- Status last verified
- Jul 2015
- First submitted
- 24 Apr 2014
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Nutritional Supplementation in Children With Picky Eating Behaviors
- ClinicalTrials.gov ID
- NCT02125123
- Acronym / sponsor ID
- AL15
- Conditions
- Children
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 29 Apr 2014 (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 will investigate the effect of an oral nutritional supplement (ONS) along with dietary counseling on improving the dietary intake among children with picky eating behaviors.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional Supplement and Counseling | Experimental | Other: Nutritional Supplement and CounselingTwo servings a day; ready-to-feed nutritional supplement plus dietary counseling |
| Counseling | Active comparator | Other: CounselingDietary Counseling |
Who may qualify
- Ages
- 36 to 109 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- ≥ 36 months and < 109 months of age.
- Healthy and not suffering from any physical disability.
- Height-for-age and BMI-for-age between the 5th and the 95th percentile; weight-for-age between the 5th and the 85th percentile.
- Capable of oral feeding.
- Has a mean score of greater than 3.0 on the fussiness category in the Children's Eating Behaviour Questionnaire and also consumes on average less than the daily recommendations for at least 3 of 5 food groups (Dietary Guidelines for America, 2010).
Key exclusion criteria (10 listed)
- History of an acute or chronic condition that may affect feeding habits or nutritional status.
- Taking any medications or nutritional supplements on a daily basis for more than 2 weeks during the past month that may profoundly affect feeding habits or nutritional status.
- Clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement.
- Any acute/chronic condition requiring medical treatment which may include hospitalization.
- Allergy or intolerance to any ingredient in the study product.
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 Supplement and CounselingReady-to-feed nutritional supplement and dietary counseling | Other | Nutritional Supplement and Counseling |
| CounselingDietary counseling | Other | Counseling |
Primary outcome
Vitamin D Intake
Time frame: Change from Baseline to Week 4
2 secondary outcomes
Macronutrient Intake
Time frame: Change from Baseline to Week 4
Micronutrient Intake
Time frame: Change from Baseline to Week 4
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
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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.
Jennifer Williams, MPH study chair
Abbott Nutrition
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Supplement and Counseling and Counseling in people with Children, run by Abbott Nutrition at 2 sites 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 6 inclusion and 10 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 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Vitamin D Intake (time frame: Change from Baseline to Week 4). 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 27 Jul 2015.