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CompletedNCT00429351Updated Feb 26, 2020

Aromatic Amino Acid Metabolism in the Pathogenesis of Kwashiorkor

An observational study in Kwashiorkor, sponsored by Baylor College of Medicine. Completed at 1 site in Jamaica. Open to participants aged 6 Months to 18 Months. Per ClinicalTrials.gov, last updated 2020-02-26.

Sponsored by Baylor College of Medicine · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
82
Ages
6 Months to 18 Months
Sex
All
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Study 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.

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Conditions studied

  • Kwashiorkor

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03

In context

Kwashiorkor

45 studies on the registry are indexed under Kwashiorkor; 5 are open to participants now.

This study's planned enrollment of 82 is close to the median of 82 across 11 observational studies indexed under Kwashiorkor.

Browse Kwashiorkor studies →

Lead sponsor

Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 110 are open to participants now.

Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Months to 18 Months
Sexes eligible
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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Criteria for exclusion will include presence of cardiovascular, hepatic, renal, gastrointestinal, metabolic disease or /AIDS.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

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Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
82 participants (estimated)
Biospecimen retention
Samples without dna
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Study locations

1 site
  • Tropical Metabolism Research Unit, University of the West Indies
    Mona, Kingston Kingston-7, Jamaica
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2006 and a completion of Jun 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 30, 2007
First posted
Jan 31, 2007
Start
Sep 2006
CompletionActual
Jun 2010
Last update
Feb 26, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00429351
Responsible party
Farook Jahoor (Professor, Pediatrics-Nutrition, Baylor College of Medicine) — Principal investigator
First posted
Jan 31, 2007
Start date
Sep 2006
Completion
Jun 2010
Last update
Feb 26, 2020
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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