Study of Antioxidants and Oxidants in Malnourished Children

Protein-energy Malnutrition Clinical Trial

Official title:

Glutathione Homeostasis and Oxidant Damage in Kwashiorkor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00069134
• Other study ID #: GLUTH - dk56689
• Secondary ID: R01DK056689
• Status: Completed
• Phase: N/A
• First received: September 15, 2003
• Last updated: July 31, 2017
• Start date: June 2003
• Est. completion date: January 2016

Study information

• Verified date: July 2017
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Months

Eligibility

• Infants and toddlers, 6-18 months of age

• Suffering from severe protein-energy malnutrition, kwashiorkor and marasmic-kwashiorkor

Related Conditions & MeSH terms

• Kwashiorkor
• Malnutrition
• Marasmus
• Protein-energy Malnutrition

Intervention

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

Locations

Country	Name	City	State
Jamaica	Tropical Metabolism Research Unit, University of the West Indies	Kingston	Saint Andrew

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

Jamaica, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	small intestine, skin function and red blood cell gluathione synthesis	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	after intervention
Primary	immune capacity	synthesis rate of selected acute phase proteins	after intervention