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Aromatic Amino Acid Metabolism in the Pathogenesis of Kwashiorkor

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00429351
First Posted: January 31, 2007
Last Update Posted: December 22, 2010
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. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Baylor College of Medicine
  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 Early Phase 1

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Farook Jahoor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00429351     History of Changes
Other Study ID Numbers: DK75018
R01DK075018 ( U.S. NIH Grant/Contract )
First Submitted: January 30, 2007
First Posted: January 31, 2007
Last Update Posted: December 22, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Kwashiorkor
Severe Acute Malnutrition
Malnutrition
Nutrition Disorders