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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00429351
Other study ID # H-16233
Secondary ID R01DK075018
Status Completed
Phase
First received
Last updated
Start date September 2006
Est. completion date June 2010

Study information

Verified date February 2020
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date June 2010
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 6 Months to 18 Months
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Jamaica Tropical Metabolism Research Unit, University of the West Indies Mona Kingston

Sponsors (2)

Lead Sponsor Collaborator
Baylor College of Medicine National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

Jamaica, 

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