Study of Antioxidants and Oxidants in Malnourished Children

Not Applicable

Completed

• Conditions: Kwashiorkor; Protein-energy Malnutrition; Marasmus
• Interventions: Dietary Supplement: sulfur amino acids

• Registration Number: NCT00069134
• Lead Sponsor: Baylor College of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2003-09-15
• Study First Submitted QC: 2003-09-16
• Study First Posted: 2003-09-17
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-31
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alanine	sulfur amino acids	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.
Sulfur Amino Acids	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.

Primary Outcome Measures

Name	Time	Method
small intestine, skin function and red blood cell gluathione synthesis	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	after intervention	synthesis rate of selected acute phase proteins

Trial Locations

Locations (1)

Tropical Metabolism Research Unit, University of the West Indies; 🇯🇲 Kingston, Saint Andrew, Jamaica