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Aromatic Amino Acid Metabolism in the Pathogenesis of Kwashiorkor

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00429351
First received: January 30, 2007
Last updated: December 21, 2010
Last verified: December 2010
History of Changes
  Purpose

This research may explain whether a shortage of three special compounds called aromatic amino acids is responsible for the severe illness and high death rate of children with the kwashiorkor type of malnutrition and whether supplying adequate amounts of these compounds in the treatment diet will speed up recovery from this condition. We propose that decreased availability of the aromatic amino acids may be the reason why children with kwashiorkor are sicker and more difficult to treat.


Condition Phase
Kwashiorkor
 Phase 0

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective

Further study details as provided by Baylor College of Medicine:

Biospecimen Retention:   Samples Without DNA

plasma, expired breath


Estimated Enrollment: 82
Study Start Date: September 2006
Study Completion Date: June 2010
  Eligibility

Ages Eligible for Study:   6 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

82 children aged 6 to 18 months and diagnosed with severe protein-energy malnutrition. By the Wellcome Classification patients will have marasmus (< 60 % weight/age and no edema), marasmic-kwashiorkor (< 60 % weight/age plus edema) or kwashiorkor (< 80 % weight/age plus edema)

Criteria

Inclusion Criteria:

  • Malnourished children between 6 to 18 months of age.
  • To standardize for degree of malnutrition, only patients whose weight is < 80 % of that expected for age will be enrolled. By the Wellcome Classification (22), enrolled patients will have marasmus (< 60 % weight/age and no edema), marasmic-kwashiorkor (< 60 % weight/age plus edema) or kwashiorkor (< 80 % weight/age plus edema).
  • Presence of infection at admission. Infection will be defined by the presence of two or more of the following: Leukocyte count >11,000 cells/dl, temperature at admission > 99 oF, positive blood or urine cultures.

Exclusion Criteria:

  • Criteria for exclusion will include presence of cardiovascular, hepatic, renal, gastrointestinal, metabolic disease or HIV/AIDS.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429351

Locations
Jamaica
Tropical Metabolism Research Unit, University of the West Indies
Mona, Kingston, Jamaica, Kingston-7
Sponsors and Collaborators
Baylor College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

No publications provided

Responsible Party: Farook Jahoor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00429351     History of Changes
Other Study ID Numbers: DK75018, R01DK075018
Study First Received: January 30, 2007
Last Updated: December 21, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Kwashiorkor
Protein-Energy Malnutrition
Protein Deficiency
 Deficiency Diseases
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on May 16, 2013