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Completed

NCT Number: NCT00069134

Study of Antioxidants and Oxidants in Malnourished Children

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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Key information

Conditions

Protein-energy Malnutrition Deficiency Diseases Kwashiorkor Malnutrition Marasmus Nutrition Disorders Nutritional and Metabolic Diseases Protein Deficiency Severe Acute Malnutrition

Age range

6 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tropical Metabolism Research Unit, University of the West Indies

Kingston, Saint Andrew Parish, Kingston-7, Jamaica

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Infants and toddlers, 6-18 months of age
  • Suffering from severe protein-energy malnutrition, kwashiorkor and marasmic-kwashiorkor

Treatment and study plan

sulfur amino acids

Dietary Supplement

Sixteen (16) children with edematous SCU will be randomly assigned to either a supplement of SAA or an isonitrogenous amount of alanine

Primary outcomes

  1. 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:

    • 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.
    • skin protein synthesis rate, rate of closure of skin lesions
    • Red blood cell glutathione synthesis rate and cysteine production

  2. immune capacity

    Time frame: after intervention

    synthesis rate of selected acute phase proteins

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Glutathione Homeostasis and Oxidant Damage in Kwashiorkor

Important dates

Study start
2003
Primary completion
2016
Study completion
2016
First posted
Sep 17, 2003
Registry last updated
Aug 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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