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Study of Antioxidants and Oxidants in Malnourished Children

Primary Purpose

Protein-energy Malnutrition, Kwashiorkor, Marasmus

Status
Completed
Phase
Not Applicable
Locations
Jamaica
Study Type
Interventional
Intervention
sulfur amino acids
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Protein-energy Malnutrition focused on measuring glutathione kinetics, oxidant damage, anti-oxidant capacity, oxidative stress, cysteine kinetics, severe childhood malnutrition

Eligibility Criteria

6 Months - 18 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tropical Metabolism Research Unit, University of the West Indies

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sulfur Amino Acids

Alanine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
immune capacity
synthesis rate of selected acute phase proteins

Secondary Outcome Measures

Full Information

First Posted
September 15, 2003
Last Updated
July 31, 2017
Sponsor
Baylor College of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00069134
Brief Title
Study of Antioxidants and Oxidants in Malnourished Children
Official Title
Glutathione Homeostasis and Oxidant Damage in Kwashiorkor
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Protein-energy Malnutrition, Kwashiorkor, Marasmus
Keywords
glutathione kinetics, oxidant damage, anti-oxidant capacity, oxidative stress, cysteine kinetics, severe childhood malnutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sulfur Amino Acids
Arm Type
Experimental
Arm Description
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.
Arm Title
Alanine
Arm Type
Placebo Comparator
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
sulfur amino acids
Intervention Description
Sixteen (16) children with edematous SCU will be randomly assigned to either a supplement of SAA or an isonitrogenous amount of alanine
Primary Outcome Measure Information:
Title
small intestine, skin function and red blood cell gluathione synthesis
Description
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
Time Frame
after intervention
Title
immune capacity
Description
synthesis rate of selected acute phase proteins
Time Frame
after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Infants and toddlers, 6-18 months of age Suffering from severe protein-energy malnutrition, kwashiorkor and marasmic-kwashiorkor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farook Jahoor, Ph.D.
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tropical Metabolism Research Unit, University of the West Indies
City
Kingston
State/Province
Saint Andrew
ZIP/Postal Code
Kingston-7
Country
Jamaica

12. IPD Sharing Statement

Citations:
PubMed Identifier
22170355
Citation
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.
Results Reference
derived

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Study of Antioxidants and Oxidants in Malnourished Children

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