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

NCT01637688 | Unknown DMC

• 1 other identifier: Si262/2012
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Cow Milk Allergy

Keywords

cow milk allergy; amino acid formula

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Growth

  4 weeks

Study Arms (1)

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.

Dietary Supplement: Comparison of treatment with different amino acid formulas

Interventions

Comparison of treatment with different amino acid formulas DIETARY_SUPPLEMENT

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

Also known as: Neocate, Nutramigen AA, a newly innovated amino acid formula

Amino acid formula

Eligibility Criteria

• Age: 1 Week - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

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

You may not qualify if:

• Other diseases

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkok, 10700, Thailand

Location

Related Publications (2)

• 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.

  PMID: 11853298 BACKGROUND

• 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.jpeds.2008.02.043. Epub 2008 Apr 9.

  PMID: 18534230 RESULT

Related Links

• Educational institute web page

MeSH Terms

Conditions

Milk Hypersensitivity

Interventions

Neocate

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Narumon Densupsoontorn, MD

  Asso.Prof. Narumon Densupsoontorn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: July 11, 2012
• Study Start: April 1, 2013
• Primary Completion: June 30, 2023
• Study Completion: July 31, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

TH (1)