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Study of Antioxidants and Oxidants in Malnourished Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00069134
First Posted: September 17, 2003
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Farook Jahoor, Baylor College of Medicine
September 15, 2003
September 17, 2003
August 1, 2017
June 2003
January 2016   (Final data collection date for primary outcome measure)
  • 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
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Complete list of historical versions of study NCT00069134 on ClinicalTrials.gov Archive Site
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Study of Antioxidants and Oxidants in Malnourished Children
Glutathione Homeostasis and Oxidant Damage in Kwashiorkor
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.
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Protein-energy Malnutrition
  • Kwashiorkor
  • Marasmus
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
  • Experimental: Sulfur Amino Acids
    12 children with edematous severe malnutrition will be assigned to receive 0.65 mmol/kg/d of sulfur amino acids. Supplements will be added to the children's daily diets.
    Intervention: Dietary Supplement: sulfur amino acids
  • Placebo Comparator: Alanine
    12 children with edematous severe malnutrition are assigned to receive 0.65 mmol/kg/d of alanine as placebo. Supplements will be added to the children's daily diets.
    Intervention: Dietary Supplement: sulfur amino acids
Badaloo A, Hsu JW, Taylor-Bryan C, Green C, Reid M, Forrester T, Jahoor F. Dietary cysteine is used more efficiently by children with severe acute malnutrition with edema compared with those without edema. Am J Clin Nutr. 2012 Jan;95(1):84-90. doi: 10.3945/ajcn.111.024323. Epub 2011 Dec 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
January 2016
January 2016   (Final data collection date for primary outcome measure)
  • Infants and toddlers, 6-18 months of age
  • Suffering from severe protein-energy malnutrition, kwashiorkor and marasmic-kwashiorkor
Sexes Eligible for Study: All
6 Months to 18 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Jamaica
 
 
NCT00069134
GLUTH - dk56689
R01DK056689 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Farook Jahoor, Baylor College of Medicine
Baylor College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Farook Jahoor, Ph.D. Baylor College of Medicine
Baylor College of Medicine
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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