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Growth and Plasma Amino Acids in Infants With CMPA and Treated With a Newly Innovated Amino Acid Formula

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)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01637688
Acronym
CMPA
Enrollment
81
Registered
2012-07-11
Start date
2013-04-01
Completion date
2023-07-31
Last updated
2023-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cow Milk Allergy

Keywords

cow milk allergy, amino acid formula

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENTComparison of treatment with different amino acid formulas

Growth and amino acid status of a newly innovated amino acid formula (NAAF) and a commercial amino acid formula (AAF)

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Weeks to 6 Months
Healthy volunteers
Yes

Inclusion criteria

* Singleton * Clinical diagnosis of cow's milk protein allergy

Exclusion criteria

* Other diseases

Design outcomes

Primary

MeasureTime frameDescription
Growth and protein status4 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

Secondary

MeasureTime frameDescription
Growth4 weeks* 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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026