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Clinical Trials/NCT01637688
NCT01637688
Active, not recruiting
Not Applicable

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)

Mahidol University1 site in 1 country81 target enrollmentApril 1, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cow Milk Allergy
Sponsor
Mahidol University
Enrollment
81
Locations
1
Primary Endpoint
Growth and protein status
Status
Active, not recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2013
End Date
July 31, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Other diseases

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Growth(4 weeks)

Study Sites (1)

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