Aromatic Amino Acid Metabolism in the Pathogenesis of Kwashiorkor

This study is currently recruiting participants.

Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), July 2008

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00429351

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

Drug Information available for: Amino acids, branched-chain

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Crossover, Prospective

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

plasma, expired breath

Estimated Enrollment:	82
Study Start Date:	September 2006

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

Contacts

Contact: Terrence Forrester, MD, PhD	1-876-702-4687	Terrence.Forrester@uwimona.edu.jm
Contact: Asha Badaloo, PhD	1-876-977-6251	asha.badaloo@uwimona.edu.jm

Locations

Jamaica, Kingston
Tropical Metabolism Research Unit, University of the West Indies	Recruiting
Mona, Kingston, Jamaica, Kingston-7
Contact: Terrence Forrester, MD 876-702-4687 terrence.forrester@uwimona.edu.jm
Contact: Asha Badaloo, PhD 876-977-6251 asah.badaloo@uwimona.edu.jm
Principal Investigator: Terrence Forrester, MD

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

More Information

Responsible Party:	Baylor College of Medicine ( Farook Jahoor )
Study ID Numbers:	DK75018
Study First Received:	January 30, 2007
Last Updated:	July 11, 2008
ClinicalTrials.gov Identifier:	NCT00429351
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Protein Deficiency
Malnutrition
Nutrition Disorders

Kwashiorkor
Protein-Energy Malnutrition
Deficiency Diseases

ClinicalTrials.gov processed this record on January 16, 2009