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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 September 2016 by Mahidol University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01637688
First Posted: July 11, 2012
Last Update Posted: September 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Mahidol University
  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:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Growth [ Time Frame: 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


Estimated Enrollment: 74
Study Start Date: April 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
  More Information

Additional Information:
Publications:
Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01637688     History of Changes
Other Study ID Numbers: Si262/2012
First Submitted: June 26, 2012
First Posted: July 11, 2012
Last Update Posted: September 22, 2016
Last Verified: September 2016

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