ChildrenPhase 3NCT01658267
Compliance With Dietary Recommendations in Children at Risk for Undernutrition
A Phase 3 study testing nutritional supplement in people with Children and Under-nutrition, run by Abbott Nutrition at 2 sites in Philippines.
Trial summary
This study will assess compliance with dietary recommendations, in conjunction with a nutritional supplement to meet the nutritional requirements in children and the effects of the compliance on promoting growth in children who are at risk of under-nutrition. Read more about this study
- Who is it for?
- Ages 36 to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Children, Under-nutrition
- What is being tested?
- nutritional supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesPhilippines
- Study dates
- Oct 2011to Oct 2012
- Phase
- Phase 3
- 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 48 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child is between 36 and 48 months of age.
- Child has weight-for-height greater than or equal to 5th and less than or equal to the 25th percentile.
- Child is capable of oral feeding.
- Child's parent(s)or Legal Guardian is willing to abstain from giving additional non-study nutritional supplements to the child throughout the study period.
Who cannot join
- Child whose either parent has BMI greater than or equal to 27.5 kg/m2.
- Child allergic or intolerant to any ingredient found in the study product.
- Child who was delivered pre-term.
- Child was born small for gestational
- Child had birth weight < 2500 g or > 4000 g.
- Child has current acute or chronic infections.
Show all 14Show fewer
- Child demonstrates presence of severe gastrointestinal disorders.
- Child has a diagnosis of neoplastic diseases, renal, hepatic and cardiovascular diseases.
- Child has a diagnosis of hormonal or metabolic disorders.
- Child has a congenital disease or genetic disorder.
- Child is diagnosed with infantile anorexia nervosa.
- Child has a developmental disability or physical disorder.
- Child has disorders of hemoglobin structure, function or synthesis.
- Child is participating in another study that has not been approved as a concomitant study.
Trial locations and contacts
2 sites in 1 country.
Philippines2 sites
Asian Hospital and Medical Center
Manila
The Medical City
Manila
About this study
Official title: Compliance With Dietary Recommendations in Meeting Nutritional Requirements in Children at Risk of Undernutrition
This study will assess compliance with dietary recommendations, in conjunction with a nutritional supplement to meet the nutritional requirements in children and the effects of the compliance on promoting growth in children who are at risk of under-nutrition.
Read the detailed description
This study will assess compliance with dietary recommendations, in conjunction with an oral nutritional supplement to meet the nutritional requirements in children older than 36 (>36) to less than or equal 48 (≤48) months of age, and the effects of the compliance on promoting catch-up growth and normal healthy growth in children who are at risk of under-nutrition.
- Conditions
- Children, Under-nutrition
- Being tested
- nutritional supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional supplementOther
Also called Pediasure S229
2 servings per day
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Supplement | Experimental | Instructions and techniques to improve the quality of the diet to meet the child's daily nutritional requirements will be provided. Receives: Other: nutritional supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with recommendation of a nutritional supplement consumption
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startOct 2011
- Primary completionOct 2012
- Study completionOct 2012
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dieu Huynh, MD, PhD, Study chair, Abbott Nutrition, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658267
- Sponsor's protocol ID
- AK86
- Status last verified
- Jan 2015
- First submitted
- 30 Jul 2012
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance With Dietary Recommendations in Meeting Nutritional Requirements in Children at Risk of Undernutrition
- ClinicalTrials.gov ID
- NCT01658267
- Acronym / sponsor ID
- AK86
- Conditions
- Children, Under-nutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 7 Aug 2012 (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 assess compliance with dietary recommendations, in conjunction with a nutritional supplement to meet the nutritional requirements in children and the effects of the compliance on promoting growth in children who are at risk of under-nutrition.
Detailed description
This study will assess compliance with dietary recommendations, in conjunction with an oral nutritional supplement to meet the nutritional requirements in children older than 36 (>36) to less than or equal 48 (≤48) months of age, and the effects of the compliance on promoting catch-up growth and normal healthy growth in children who are at risk of under-nutrition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutritional Supplement | Experimental | Other: nutritional supplementInstructions and techniques to improve the quality of the diet to meet the child's daily nutritional requirements will be provided. |
Who may qualify
- Ages
- 36 to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child is between 36 and 48 months of age.
- Child has weight-for-height greater than or equal to 5th and less than or equal to the 25th percentile.
- Child is capable of oral feeding.
- Child's parent(s)or Legal Guardian is willing to abstain from giving additional non-study nutritional supplements to the child throughout the study period.
Key exclusion criteria (14 listed)
- Child whose either parent has BMI greater than or equal to 27.5 kg/m2.
- Child allergic or intolerant to any ingredient found in the study product.
- Child who was delivered pre-term.
- Child was born small for gestational
- Child had birth weight < 2500 g or > 4000 g.
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 supplementAlso: Pediasure S2292 servings per day | Other | Nutritional Supplement |
Primary outcome
Compliance with recommendation of a nutritional supplement consumption
Time frame: 48 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 21 Jan 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.
Dieu Huynh, MD, PhD study chair
Abbott Nutrition, Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nutritional supplement in people with Children and Under-nutrition, run by Abbott Nutrition at 2 sites in Philippines.
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 4 inclusion and 14 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 21 Jan 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 Philippines. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Compliance with recommendation of a nutritional supplement consumption (time frame: 48 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 21 Jan 2015.