Study of Antioxidants and Oxidants in Malnourished Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Baylor College of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Farook Jahoor, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00069134
First received: September 15, 2003
Last updated: August 13, 2013
Last verified: August 2013
  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:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • small intestine, skin function and red blood cell gluathione synthesis [ Time Frame: after intervention ] [ Designated as safety issue: No ]

    The effect of dietary supplementation with either a mixture of SAAs or alanine (controls) on:

    1. buccal tissue protein synthesis, 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.
    2. skin protein synthesis rate, rate of closure of skin lesions
    3. Red blood cell glutathione synthesis rate and cysteine production


Estimated Enrollment: 84
Study Start Date: June 2003
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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: Farook Jahoor, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00069134     History of Changes
Other Study ID Numbers: GLUTH - dk56689, R01DK056689
Study First Received: September 15, 2003
Last Updated: August 13, 2013
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:
Malnutrition
Nutrition Disorders
Kwashiorkor
Protein-Energy Malnutrition
Protein Deficiency
Deficiency Diseases

ClinicalTrials.gov processed this record on October 01, 2014