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

March 22, 2023 updated by: Mahidol University

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 6 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Other diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Growth and amino acid status of a newly innovated amino acid formula (NAAF) and a commercial amino acid formula (AAF)
Other Names:
  • Neocate
  • Nutramigen AA
  • a newly innovated amino acid formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Narumon Densupsoontorn, MD, Asso.Prof. Narumon Densupsoontorn

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

July 31, 2023

Study Registration Dates

First Submitted

June 26, 2012

First Submitted That Met QC Criteria

July 8, 2012

First Posted (Estimate)

July 11, 2012

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si262/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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