Cow Milk AllergyCMPANCT01637688
Growth and Plasma Amino Acids in Infants With CMPA and Treated With a Newly Innovated Amino Acid Formula
An observational study of Cow Milk Allergy, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine growth and protein status of infants with cow's milk protein allergy and treated with a newly innovated amino acid formula compared to those with a commercial amino acid formula. Read more about this study
- Who is it for?
- Ages 1 week to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Cow Milk Allergy
- What is being tested?
- Comparison of treatment with different amino acid formulas
- How many people
- 81 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2013to 31 Jul 2023
- Phase
- Observational
- 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 week to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: * population who are diagnosed cow's milk protein allergy via a double-blind placebo-controlled food challenge and consume either a newly innovated amino acid formula or a commercial amino acid formula * population from a well-baby clinic
Who may be able to join
- Singleton
- Clinical diagnosis of cow's milk protein allergy
Who cannot join
- Other diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Growth and Plasma Amino Acid Levels in Infants With Cow's Milk Protein Allergy and Treated With a Newly Innovated Amino Acid Formula (NAAF) Compared to a Commercial Amino Acid Formula (AAF)
The purpose of this study is to determine growth and protein status of infants with cow's milk protein allergy and treated with a newly innovated amino acid formula compared to those with a commercial amino acid formula.
Read the detailed description
Severe cases of cow's milk protein allergy are treated with the amino acid formula. The amino acid formula is composed of essential and non-essential amino acids, vegetable oils with or without MCT oil, and glucose polymer from various carbohydrate sources. Such formula is also fortified by minerals, trace elements,and vitamins.
- Conditions
- Cow Milk Allergy
- Being tested
- Comparison of treatment with different amino acid formulas
- Keywords
- cow milk allergy, amino acid formula
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of treatment with different amino acid formulasDietary supplement
Also called Neocate, Nutramigen AA, a newly innovated amino acid formula
Growth and amino acid status of a newly innovated amino acid formula (NAAF) and a commercial amino acid formula (AAF)
| Study group | Role | What they receive |
|---|---|---|
| Amino acid formula | Comparison of growth between subjects who are fed with a newly innovated amino acid formula (NAAF) and who are fed with either Neocate or nutramigen AA. Receives: Dietary Supplement: Comparison of treatment with different amino acid formulas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth and protein status
- compare body weight, length, head circumference, triceps skin fold thickness, mid-arm circumference, and arm muscle area between NAAF and AAF groups
- compare plasma amino acids, serum albumin, blood urea nitrogen, and creatinine between NAAF and AAF groups
Measured: 4 weeks
Secondary outcomes (1)
Growth
- compare weight, length, head circumference, triceps skin fold thickness, mid-arm circumference, and arm muscle area between either NAAF group or AAF group and normal infants fed with either breast milk or infant formula.
- compare plasma amino acids between either NAAF group or AAF group and normal published data
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study start1 Apr 2013
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cow Milk AllergyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Narumon Densupsoontorn, MD, Principal investigator, Asso.Prof. Narumon Densupsoontorn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637688
- Sponsor's protocol ID
- Si262/2012
- Acronym
- CMPA
- Status last verified
- Mar 2023
- First submitted
- 26 Jun 2012
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Svasti J, Wasant P, Tiensuwan M, Sawangareetrakul P, Srisomsap C, Pangkanon S, Boonpuan K, Liammongkolkul S. Normal plasma free amino acid levels in Thai children. J Med Assoc Thai. 2001 Nov;84(11):1558-68.
PubMed 11853298Burks W, Jones SM, Berseth CL, Harris C, Sampson HA, Scalabrin DM. Hypoallergenicity and effects on growth and tolerance of a new amino acid-based formula with docosahexaenoic acid and arachidonic acid. J Pediatr. 2008 Aug;153(2):266-71. doi: 10.1016/j.jpeds.2008.02.043. Epub 2008 Apr 9.
PubMed 18534230
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Plasma Amino Acid Levels in Infants With Cow's Milk Protein Allergy and Treated With a Newly Innovated Amino Acid Formula (NAAF) Compared to a Commercial Amino Acid Formula (AAF)
- ClinicalTrials.gov ID
- NCT01637688
- Acronym / sponsor ID
- CMPA / Si262/2012
- Conditions
- Cow Milk Allergy
- Keywords
- cow milk allergy, amino acid formula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 11 Jul 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.
The purpose of this study is to determine growth and protein status of infants with cow's milk protein allergy and treated with a newly innovated amino acid formula compared to those with a commercial amino acid formula.
Detailed description
Severe cases of cow's milk protein allergy are treated with the amino acid formula. The amino acid formula is composed of essential and non-essential amino acids, vegetable oils with or without MCT oil, and glucose polymer from various carbohydrate sources. Such formula is also fortified by minerals, trace elements,and vitamins.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amino acid formula | – | Dietary Supplement: Comparison of treatment with different amino acid formulasComparison of growth between subjects who are fed with a newly innovated amino acid formula (NAAF) and who are fed with either Neocate or nutramigen AA. |
Who may qualify
- Ages
- 1 week to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- * population who are diagnosed cow's milk protein allergy via a double-blind placebo-controlled food challenge and consume either a newly innovated amino acid formula or a commercial amino acid formula * population from a well-baby clinic
Key inclusion criteria (2 listed)
- Singleton
- Clinical diagnosis of cow's milk protein allergy
Key exclusion criteria (1 listed)
- Other diseases
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 |
|---|---|---|
| Comparison of treatment with different amino acid formulasAlso: Neocate, Nutramigen AA, a newly innovated amino acid formulaGrowth and amino acid status of a newly innovated amino acid formula (NAAF) and a commercial amino acid formula (AAF) | Dietary supplement | Amino acid formula |
Primary outcome
Growth and protein status
Time frame: 4 weeks
* compare body weight, length, head circumference, triceps skin fold thickness, mid-arm circumference, and arm muscle area between NAAF and AAF groups * compare plasma amino acids, serum albumin, blood urea nitrogen, and creatinine between NAAF and AAF groups
1 secondary outcome
Growth
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Background: PubMed 11853298Svasti J, Wasant P, Tiensuwan M, Sawangareetrakul P, Srisomsap C, Pangkanon S, Boonpuan K, Liammongkolkul S. Normal plasma free amino acid levels in Thai children. J Med Assoc Thai. 2001 Nov;84(11):1558-68.
- Results publication: PubMed 18534230Burks W, Jones SM, Berseth CL, Harris C, Sampson HA, Scalabrin DM. Hypoallergenicity and effects on growth and tolerance of a new amino acid-based formula with docosahexaenoic acid and arachidonic acid. J Pediatr. 2008 Aug;153(2):266-71. doi: 10.1016/j.jpeds.2008.02.043. Epub 2008 Apr 9.
- Educational institute web pageLink provided by the sponsor.
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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.
Narumon Densupsoontorn, MD principal investigator
Asso.Prof. Narumon Densupsoontorn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cow Milk Allergy, run by Mahidol University at 1 site in Thailand.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Mar 2023. 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 Thailand. 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?
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?
Growth and protein status (time frame: 4 weeks). 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 NCT01637688, which also lists 2 linked publications.
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 24 Mar 2023.