Text Size

Study of Antioxidants and Oxidants in Malnourished Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Baylor College of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00069134
First received: September 15, 2003
Last updated: October 6, 2010
Last verified: October 2010
History of Changes
  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
 Dietary Supplement: sulfur amino acids
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Glutathione Homeostasis and Oxidant Damage in Kwashiorkor

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • small intestine function [ Time Frame: after intervention ] [ Designated as safety issue: No ]
    The effect of dietary supplementation with either a mixture of SAAs or alanine (controls) on small intestine structure, integrity and function (i.e. mixed mucosal and mucins protein synthesis rate, mucosal GSH synthesis and concentration, villous height and area and crypt depth, intestinal absorptive capacity and degree of mucosal leakiness, and synthesis of the starch digestive enzymes sucrase-isomaltase and maltase-glucoamylase, plus in vivo starch digestion and absorption) in groups of age- and gender-matched children with edematous SCU in the severely malnourished state


Estimated Enrollment: 84
Study Start Date: June 2003
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: sulfur amino acids
    Sixteen (16) children with edematous SCU will be randomly assigned to either a supplement of SAA or an isonitrogenous amount of alanine
  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
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
Baylor College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Farook Jahoor, Ph.D. Baylor College of Medicine
  More Information

No publications provided by Baylor College of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Helen Sheperd, Executive Director, Office of Research
ClinicalTrials.gov Identifier: NCT00069134     History of Changes
Other Study ID Numbers: GLUTH - dk56689, R01DK056689
Study First Received: September 15, 2003
Last Updated: October 6, 2010
Health Authority: United States: Federal Government

Keywords provided by Baylor College of Medicine:
glutathione kinetics
oxidant damage
anti-oxidant capacity
 oxidative stress
cysteine kinetics
severe childhood malnutrition

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

ClinicalTrials.gov processed this record on May 21, 2013