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NCT01637688 Clinical Trial

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

Cow Milk Allergy Clinical Trial

— CMPA  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01637688
Other study ID # Si262/2012
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 1, 2013
Est. completion date July 31, 2023

Study information
Verified date March 2023
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 81
Est. completion date July 31, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Week to 6 Months
Eligibility Inclusion Criteria: - Singleton - Clinical diagnosis of cow's milk protein allergy Exclusion Criteria: - Other diseases

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Comparison 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)

Locations
Country Name City State
Thailand Faculty of Medicine Siriraj Hospital Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (2)

Burks 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.jp — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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		 4 weeks
Secondary 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		 4 weeks
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Completed NCT03236207 - Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula N/A
Active, not recruiting NCT03644381 - Milk Desensitization in Children N/A
Active, not recruiting NCT04249973 - Detection of Metabolite Biomarkers for the Early Diagnosis and Prognosis of Cow's Milk Allergy in Children
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