Aromatic Amino Acid Metabolism in the Pathogenesis of Kwashiorkor

NCT ID: NCT00429351

Last Updated: 2020-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-09-30

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Kwashiorkor

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Farook Jahoor

Professor, Pediatrics-Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tropical Metabolism Research Unit, University of the West Indies

Mona, Kingston, Jamaica

Site Status

Countries

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Jamaica

Other Identifiers

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R01DK075018

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-16233

Identifier Type: -

Identifier Source: org_study_id

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