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

Active, not recruiting

• Conditions: Cow Milk Allergy
• Interventions: Dietary Supplement: Comparison of treatment with different amino acid formulas

• Registration Number: NCT01637688
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-07-08
• Study First Posted: 2012-07-11
• Study Start: 2013-04-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-24
• Primary Completion: 2023-06-30
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

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

Exclusion Criteria

• Other diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Amino acid formula	Comparison of treatment with different amino acid formulas	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.

Primary Outcome Measures

Name	Time	Method
Growth and protein status	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

Secondary Outcome Measures

Name	Time	Method
Growth	4 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

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkok, Thailand