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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

September 15, 2003
August 13, 2013
June 2003
March 2014   (final data collection date for primary outcome measure)
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
Not Provided
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Not Provided
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.
 
Recruiting
84
March 2014
March 2014   (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
Both
6 Months to 18 Months
No
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
Jamaica
 
NCT00069134
GLUTH - dk56689, R01DK056689
Yes
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
August 2013

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