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Study of Antioxidants and Oxidants in Malnourished Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Farook Jahoor, Baylor College of Medicine.
Recruitment status was:  Recruiting
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Farook Jahoor, Baylor College of Medicine Identifier:
First received: September 15, 2003
Last updated: January 27, 2015
Last verified: January 2015
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Glutathione Homeostasis and Oxidant Damage in Kwashiorkor

Resource links provided by NLM:

Further study details as provided by Farook Jahoor, Baylor College of Medicine:

Primary Outcome Measures:
  • small intestine, skin function and red blood cell gluathione synthesis [ Time Frame: after intervention ]

    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

  • immune capacity [ Time Frame: after intervention ]
    synthesis rate of selected acute phase proteins

Estimated Enrollment: 84
Study Start Date: June 2003
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sulfur Amino Acids
24 children with edematous severe malnutrition are randomly assigned to either 0.65 mmol/kg/d of sulfur amino acids or isonitrogenous alanine as placebo. Supplements will be added to the children's daily diets.
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


Ages Eligible for Study:   6 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Infants and toddlers, 6-18 months of age
  • Suffering from severe protein-energy malnutrition, kwashiorkor and marasmic-kwashiorkor
  Contacts and Locations
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Please refer to this study by its identifier: NCT00069134

Contact: Marvin Reid, MBBS, Ph.D. 876-702-4729
Contact: Asha Badaloo, Ph.D. 876-702-4421

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   
Contact: Marvin Reid, MB.BS, Ph.D.    876-702-4729   
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)
Principal Investigator: Farook Jahoor, Ph.D. Baylor College of Medicine
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Farook Jahoor, Professor, Baylor College of Medicine Identifier: NCT00069134     History of Changes
Other Study ID Numbers: GLUTH - dk56689
R01DK056689 ( US NIH Grant/Contract Award Number )
Study First Received: September 15, 2003
Last Updated: January 27, 2015

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

Additional relevant MeSH terms:
Protein-Energy Malnutrition
Nutrition Disorders
Protein Deficiency
Deficiency Diseases
Severe Acute Malnutrition processed this record on June 23, 2017