NCT00429351

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2007

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

First QC Date

January 30, 2007

Last Update Submit

February 24, 2020

Conditions

Eligibility Criteria

Age6 Months - 18 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tropical Metabolism Research Unit, University of the West Indies

Mona, Kingston, Kingston-7, Jamaica

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma, expired breath

MeSH Terms

Conditions

Kwashiorkor

Condition Hierarchy (Ancestors)

Severe Acute MalnutritionMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Pediatrics-Nutrition

Study Record Dates

First Submitted

January 30, 2007

First Posted

January 31, 2007

Study Start

September 1, 2006

Study Completion

June 1, 2010

Last Updated

February 26, 2020

Record last verified: 2020-02

Locations