- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00429351
Aromatic Amino Acid Metabolism in the Pathogenesis of Kwashiorkor
February 24, 2020 updated by: Farook Jahoor, Baylor College of Medicine
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
82
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kingston
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Mona, Kingston, Jamaica, Kingston-7
- Tropical Metabolism Research Unit, University of the West Indies
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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)
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
January 30, 2007
First Submitted That Met QC Criteria
January 30, 2007
First Posted (Estimate)
January 31, 2007
Study Record Updates
Last Update Posted (Actual)
February 26, 2020
Last Update Submitted That Met QC Criteria
February 24, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-16233
- R01DK075018 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Kwashiorkor
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Tufts UniversityAction Contre la Faim; World Concern; Rebuild Hope for Africa; Dignitas InternationalCompletedKwashiorkorCongo, The Democratic Republic of the
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HAN University of Applied SciencesFrieslandCampina; HAS Hogeschool; Centre of Expertise Food (CoE Food); SligroCompletedMalnutrition; Protein | Protein MalnutritionNetherlands
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Washington University School of MedicineKamuzu University of Health SciencesWithdrawnKwashiorkor | MarasmusMalawi
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Washington University School of MedicineCompletedKwashiorkor | MarasmusMalawi
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Academy of Nutrition and DieteticsHartford Hospital; University of New Mexico; Meals on Wheels Central TexasNot yet recruiting
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Diego MorettiSwiss Federal Institute of Technology; Wageningen University and Research; St... and other collaboratorsCompletedMalnutrition; ProteinSwitzerland
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International Centre for Diarrhoeal Disease Research...CompletedProtein MalnutritionBangladesh
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University of HohenheimCompleted
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University GhentInstitut de Recherche en Sciences de la Sante, Burkina Faso; Centre Muraz; University...CompletedSevere Acute Malnutrition | Kwashiorkor | Nutritional EdemaBurkina Faso
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University of Nove de JulhoUnknownMalnutrition, ChildBrazil