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Study of Antioxidants and Oxidants in Malnourished Children
This study is currently recruiting participants.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), March 2009
First Received: September 15, 2003   Last Updated: March 17, 2009   History of Changes
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00069134
  Purpose

It is believed that the organs of severely malnourished children malfunction because harmful compounds called oxidants injure the tissues in these organs. In a healthy person oxidants are made harmless because another compound called glutathione neutralizes them. Glutathione is made from three amino acids that we get from the protein we eat in our food. We found that malnourished children were not making enough glutathione because they lacked one of these amino acids called cysteine. In this study we determine why malnourished children do not have sufficient cysteine, and we will feed malnourished children a whey-based diet which is rich in cysteine during their treatment to determine whether they will make more glutathione. This in turn may make their organs recover faster. These findings will let us know whether malnourished children can recover faster if they are given more cysteine during the early phase of treatment.


Condition Intervention Phase
Protein-Energy Malnutrition
Kwashiorkor
Marasmus
Behavioral: cysteine-rich whey based formula
Phase I

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Glutathione Homeostasis and Oxidant Damage in Kwashiorkor

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment: 84
Study Start Date: June 2003
Estimated Study Completion Date: October 2007
  Eligibility

Ages Eligible for Study:   6 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Infants and toddlers, 6-18 months of age
  • Suffering from severe protein-energy malnutrition, kwashiorkor and marasmic-kwashiorkor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00069134

Contacts
Contact: Marvin Reid, MBBS, Ph.D. 876-702-4729 marvin.reid@uwimona.edu.jm
Contact: Asha Badaloo, Ph.D. 876-702-4421 asha.badaloo@uwimona.edu.jm

Locations
Jamaica, Saint Andrew
Tropical Metabolism Research Unit, University of the West Indies Recruiting
Kingston, Saint Andrew, Jamaica, Kingston-7
Contact: Terrence Forrester, M.D., Ph.D.     876-702-4687     terrence.forrester@uwimona.edu.jm    
Contact: Marvin Reid, MB.BS, Ph.D.     876-702-4729     marvin.reid@uwimona.edu.jm    
Principal Investigator: Terrence Forrester, M.D., Ph.D.            
Sponsors and Collaborators
Investigators
Principal Investigator: Farook Jahoor, Ph.D. Baylor College of Medicine
  More Information

No publications provided

Study ID Numbers: GLUTH - dk56689
Study First Received: September 15, 2003
Last Updated: March 17, 2009
ClinicalTrials.gov Identifier: NCT00069134     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
glutathione kinetics
oxidant damage
anti-oxidant capacity
oxidative stress
cysteine kinetics
severe childhood malnutrition

Additional relevant MeSH terms:
Antioxidants
Protein Deficiency
Malnutrition
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nutrition Disorders
Kwashiorkor
Protein-Energy Malnutrition
Protective Agents
Pharmacologic Actions
Deficiency Diseases

ClinicalTrials.gov processed this record on November 22, 2009