Cow's Milk AllergyNCT01470768
Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based (AA) Formulas
A study testing Amino Acid-based Formula with high DHA and ARA and Amino Acid-based Formula with lower DHA and ARA in people with Cow's Milk Allergy and Intolerance to Extensively Hydrolyzed Formulas, run by Mead Johnson Nutrition at 1 site in United Kingdom.
Trial summary
This clinical trial will compare the amount of fatty acids in whole blood of babies fed one of two study formulas for 4 months. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Cow's Milk Allergy, Intolerance to Extensively Hydrolyzed Formulas, Intolerance to Breast Milk
- What is being tested?
- Amino Acid-based Formula with high DHA and ARA and Amino Acid-based Formula with lower DHA and ARA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to Dec 2013
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 0 to 6 months of age inclusive
- Born at ≥ 37 weeks gestation
- Birth weight of 2500 g (5 lb 8 oz) or more
- Infants suspected to be cow's milk allergic and who do not tolerate extensively hydrolyzed formula OR infants intolerant to breast milk
- Infants with symptoms suggestive of cow's milk allergy
- Signed Informed Consent
Who cannot join
- Infants who for whatever reasons were not discharged home as per routine
- Infants with metabolic illness requiring a special formula
- Infants fed with nasogastric tube
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Great Ormand Street Hospital and Institute of Child Health
London, United Kingdon, WC1N1EH
About this study
Official title: Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based Formulas
This clinical trial will compare the amount of fatty acids in whole blood of babies fed one of two study formulas for 4 months.
- Conditions
- Cow's Milk Allergy, Intolerance to Extensively Hydrolyzed Formulas, Intolerance to Breast Milk
- Being tested
- Amino Acid-based Formula with high DHA and ARA, Amino Acid-based Formula with lower DHA and ARA
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino Acid-based Formula with high DHA and ARAOther
Amino Acid-based Formula with lower DHA and ARAOther
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - AA Formula with DHA and ARA | Other | Marketed AA formula with Docosahexanoic Acid (DHA) and Arachidonic Acid (ARA) Receives: Other: Amino Acid-based Formula with high DHA and ARA |
| Arm 2 - AA Formula with alternative levels of DHA and ARA | Other | Not described Receives: Other: Amino Acid-based Formula with lower DHA and ARA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of fatty acids in whole blood of infants
Measured: 4 months
Secondary outcomes (8)
body weight
Measured: 4 months
Occurrence of allergic manifestations
Measured: 4 months
Occurrence of adverse events
Measured: 4 months
Incidence of gas
Measured: 4 months
Incidence of fussiness
Measured: 4 months
Stool characteristics
Measured: 4 months
Body length
Measured: 4 months
Head Circumference
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Why it stopped: Sponsor cancelled study
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 Cow's Milk AllergyStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nikhil Thapar, M.D., Principal investigator, UCL Institute of Child Health and Great Ormond Street Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470768
- Sponsor's protocol ID
- 6005
- Status last verified
- Mar 2012
- First submitted
- 26 Oct 2011
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
PubMed 33006765
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based Formulas
- ClinicalTrials.gov ID
- NCT01470768
- Acronym / sponsor ID
- 6005
- Conditions
- Cow's Milk Allergy, Intolerance to Extensively Hydrolyzed Formulas, Intolerance to Breast Milk
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor cancelled study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 11 Nov 2011 (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 compare the amount of fatty acids in whole blood of babies fed one of two study formulas for 4 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - AA Formula with DHA and ARA | Other | Other: Amino Acid-based Formula with high DHA and ARAMarketed AA formula with Docosahexanoic Acid (DHA) and Arachidonic Acid (ARA) |
| Arm 2 - AA Formula with alternative levels of DHA and ARA | Other | Other: Amino Acid-based Formula with lower DHA and ARA |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 0 to 6 months of age inclusive
- Born at ≥ 37 weeks gestation
- Birth weight of 2500 g (5 lb 8 oz) or more
- Infants suspected to be cow's milk allergic and who do not tolerate extensively hydrolyzed formula OR infants intolerant to breast milk
- Infants with symptoms suggestive of cow's milk allergy
Key exclusion criteria (3 listed)
- Infants who for whatever reasons were not discharged home as per routine
- Infants with metabolic illness requiring a special formula
- Infants fed with nasogastric tube
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 |
|---|---|---|
| Amino Acid-based Formula with high DHA and ARA | Other | Arm 1 - AA Formula with DHA and ARA |
| Amino Acid-based Formula with lower DHA and ARA | Other | Arm 2 - AA Formula with alternative levels of DHA and ARA |
Primary outcome
Level of fatty acids in whole blood of infants
Time frame: 4 months
8 secondary outcomes
body weight
Time frame: 4 months
Occurrence of allergic manifestations
Time frame: 4 months
Occurrence of adverse events
Time frame: 4 months
Incidence of gas
Time frame: 4 months
Incidence of fussiness
Time frame: 4 months
Stool characteristics
Time frame: 4 months
Body length
Time frame: 4 months
Head Circumference
Time frame: 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2012.
- Derived from this study: PubMed 33006765Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
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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.
Nikhil Thapar, M.D. principal investigator
UCL Institute of Child Health and Great Ormond Street Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amino Acid-based Formula with high DHA and ARA and Amino Acid-based Formula with lower DHA and ARA in people with Cow's Milk Allergy and Intolerance to Extensively Hydrolyzed Formulas, run by Mead Johnson Nutrition at 1 site in United Kingdom.
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 3 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: withdrawn, as of the sponsor's last update on 22 Mar 2012. 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 Kingdom. 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 withdrawn before enrolling participants, so there are no results.
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?
Level of fatty acids in whole blood of infants (time frame: 4 months). 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 NCT01470768, 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 22 Mar 2012.