Growth FailureNCT02419599
High vs Standard Energy Children's Drink Study
A study testing HE ONS and SE ONS in people with Growth Failure, run by Nutricia UK Ltd.
Trial summary
This study is a pilot trial investigating the effects of a high energy drink for children, in comparison to standard energy drink for children. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Growth Failure
- What is being tested?
- HE ONS and SE ONS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Aug 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female
- Aged 1-12yrs
- Faltering growth and/or requiring oral nutritional supplements to meet nutritional requirements
- Expected to receive at least one bottle of the study product per day
- Able to take study products orally during the study period
- Written informed consent from parent/carer
Who cannot join
- Requirement for 100% of their nutrition via enteral tube and/or parenteral feeding.
- Children with major hepatic or renal dysfunction
- Children with galactosaemia or severe lactose intolerance
- Requirement for elemental or semi-elemental feeds
- Investigator concern around willingness/ability of child/parent/carer to comply with protocol requirements
- Participation in other studies within 2 weeks of study
About this study
Official title: The Effect of Standard Versus High Energy Density, Low Volume Oral Nutritional Supplements in Children Requiring Nutritional Support - a Pilot Trial
This study is a pilot trial investigating the effects of a high energy drink for children, in comparison to standard energy drink for children.
Read the detailed description
A four week, multi-centre, randomised controlled trial investigating the effects of a high energy density, low volume oral nutritional supplement versus standard energy density oral nutritional supplements in children aged 1-12yrs old requiring nutritional support. Fifty eligible children will be recruited and randomised to receive either the high energy density oral nutritional supplement or the standard energy density oral nutritional supplement for four weeks. The primary outcome is nutrient intake, with secondary outcomes of compliance, tolerance, acceptability, anthropometry and safety.
- Conditions
- Growth Failure
- Being tested
- HE ONS, SE ONS
- Medical subject headings
- Failure to Thrive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HE ONSOther
High energy density, low volume oral nutritional supplement (HE ONS) in addition to appropriate nutritional management
SE ONSOther
Standard energy density oral nutritional supplement (SE ONS) in addition to appropriate nutritional management
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | The group who will receive high energy density, low volume oral nutritional supplement, to be taken for 4 weeks (28 days) Receives: Other: HE ONS |
| Group B | Active comparator | The group who will receive the standard energy density oral nutritional supplement, to be taken for 4 weeks (28 days) Receives: Other: SE ONS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrient intake
Dietary intake, including the intake of all foods and fluids, will be recorded and analysed throughout the study.
Measured: 4 weeks (28 days)
Secondary outcomes (5)
Compliance: Compliance with oral nutritional supplements in Group A and Group B; how much of the oral nutritional supplement is taken in comparison to the amount advised by the Dietitian.
Measured: 4 weeks (28 days)
Tolerance: How well the child tolerates the oral nutritional supplements (including changes to gastrointestinal symptoms)
Measured: 4 weeks (28 days)
Acceptability: How acceptable the oral nutritional supplement is to the child and their parent/carer, including taste, texture, ease of use, etc.
Measured: 4 weeks (28 days)
Anthropometry
Changes to weight, height and head circumference in children less than 2yrs of age.
Measured: 4 weeks (28 days)
Safety assessed by adverse events, to be recorded throughout study.
Measured: 4 weeks (28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth FailureStudies 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
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419599
- Sponsor's protocol ID
- FC125
- Status last verified
- Oct 2017
- First submitted
- 14 Apr 2015
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Hubbard GP, Fry C, Sorensen K, Casewell C, Collins L, Cunjamalay A, Simpson M, Wall A, Van Wyk E, Ward M, Hallowes S, Duggan H, Robison J, Gane H, Pope L, Clark J, Stratton RJ. Energy-dense, low-volume paediatric oral nutritional supplements improve total nutrient intake and increase growth in paediatric patients requiring nutritional support: results of a randomised controlled pilot trial. Eur J Pediatr. 2020 Sep;179(9):1421-1430. doi: 10.1007/s00431-020-03620-9. Epub 2020 Mar 13.
PubMed 32170451
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Standard Versus High Energy Density, Low Volume Oral Nutritional Supplements in Children Requiring Nutritional Support - a Pilot Trial
- ClinicalTrials.gov ID
- NCT02419599
- Acronym / sponsor ID
- FC125
- Conditions
- Growth Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Nutricia UK LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 17 Apr 2015 (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 is a pilot trial investigating the effects of a high energy drink for children, in comparison to standard energy drink for children.
Detailed description
A four week, multi-centre, randomised controlled trial investigating the effects of a high energy density, low volume oral nutritional supplement versus standard energy density oral nutritional supplements in children aged 1-12yrs old requiring nutritional support. Fifty eligible children will be recruited and randomised to receive either the high energy density oral nutritional supplement or the standard energy density oral nutritional supplement for four weeks. The primary outcome is nutrient intake, with secondary outcomes of compliance, tolerance, acceptability, anthropometry and safety.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: HE ONSThe group who will receive high energy density, low volume oral nutritional supplement, to be taken for 4 weeks (28 days) |
| Group B | Active comparator | Other: SE ONSThe group who will receive the standard energy density oral nutritional supplement, to be taken for 4 weeks (28 days) |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female
- Aged 1-12yrs
- Faltering growth and/or requiring oral nutritional supplements to meet nutritional requirements
- Expected to receive at least one bottle of the study product per day
- Able to take study products orally during the study period
Key exclusion criteria (6 listed)
- Requirement for 100% of their nutrition via enteral tube and/or parenteral feeding.
- Children with major hepatic or renal dysfunction
- Children with galactosaemia or severe lactose intolerance
- Requirement for elemental or semi-elemental feeds
- Investigator concern around willingness/ability of child/parent/carer to comply with protocol requirements
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 |
|---|---|---|
| HE ONSHigh energy density, low volume oral nutritional supplement (HE ONS) in addition to appropriate nutritional management | Other | Group A |
| SE ONSStandard energy density oral nutritional supplement (SE ONS) in addition to appropriate nutritional management | Other | Group B |
Primary outcome
Nutrient intake
Time frame: 4 weeks (28 days)
Dietary intake, including the intake of all foods and fluids, will be recorded and analysed throughout the study.
5 secondary outcomes
Compliance: Compliance with oral nutritional supplements in Group A and Group B; how much of the oral nutritional supplement is taken in comparison to the amount advised by the Dietitian.
Time frame: 4 weeks (28 days)
Tolerance: How well the child tolerates the oral nutritional supplements (including changes to gastrointestinal symptoms)
Time frame: 4 weeks (28 days)
Acceptability: How acceptable the oral nutritional supplement is to the child and their parent/carer, including taste, texture, ease of use, etc.
Time frame: 4 weeks (28 days)
Anthropometry
Time frame: 4 weeks (28 days)
Safety assessed by adverse events, to be recorded throughout study.
Time frame: 4 weeks (28 days)
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 1 Nov 2017.
- Derived from this study: PubMed 32170451Hubbard GP, Fry C, Sorensen K, Casewell C, Collins L, Cunjamalay A, Simpson M, Wall A, Van Wyk E, Ward M, Hallowes S, Duggan H, Robison J, Gane H, Pope L, Clark J, Stratton RJ. Energy-dense, low-volume paediatric oral nutritional supplements improve total nutrient intake and increase growth in paediatric patients requiring nutritional support: results of a randomised controlled pilot trial. Eur J Pediatr. 2020 Sep;179(9):1421-1430. doi: 10.1007/s00431-020-03620-9. Epub 2020 Mar 13.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing HE ONS and SE ONS in people with Growth Failure, run by Nutricia UK Ltd.
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 6 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 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Nutrient intake (time frame: 4 weeks (28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02419599, which also lists 1 linked publication.
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 1 Nov 2017.