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

This study is currently recruiting participants.
Verified May 2013 by Mahidol University
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01637688
First received: June 26, 2012
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Cow Milk Allergy
 Dietary Supplement: Comparison of treatment with different amino acid formulas
 Phase 1
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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 Compared to a Commercial Amino Acid Formula

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Growth and protein status [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    • 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:
  • Growth [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    • 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


Estimated Enrollment: 74
Study Start Date: April 2013
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
amino acid formula
Newly innovated amino acid formula Commercial amino acid formula
 Dietary Supplement: Comparison of treatment with different amino acid formulas
Growth and amino acid status of a newly innovated amino acid formula and a commercial amino acid formula
Other Names:
  • Neocate
  • Nutramigen AA
  • a newly innovated 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.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Other diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637688

Contacts
Contact: Narumon Densupsoontorn, MD 662 4197000 ext 5947 narumon.den@mahidol.ac.th
Contact: Pipop Jirapinyo, MD 662 4197000 ext 5946 pipop.jir@mahidol.ac.th

Locations
Thailand
Faculty of Medicine Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Contact: Narumon Densupsoontorn, MD     662 4197000 ext 5947     narumon.den@mahidol.ac.th    
Contact: Pipop Densupsoontorn, MD     662 4197000 ext 5946     pipop.jir@mahidol.ac.th    
Principal Investigator: Narumon Densupsoontorn, MD            
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Narumon Densupsoontorn, MD Siriraj Hospital, Mahidol University
  More Information

Additional Information:
Educational institute web page  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01637688     History of Changes
Other Study ID Numbers: Si262/2012
Study First Received: June 26, 2012
Last Updated: May 1, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
cow milk allergy
amino acid formula

Additional relevant MeSH terms:
Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on May 23, 2013