NCT00069134

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2003

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

12.6 years

First QC Date

September 15, 2003

Last Update Submit

July 31, 2017

Conditions

Protein-energy MalnutritionKwashiorkorMarasmus

Keywords

glutathione kineticsoxidant damageanti-oxidant capacityoxidative stresscysteine kineticssevere childhood malnutrition

Outcome Measures

Primary Outcomes (2)

  • 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: 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

    after intervention

  • immune capacity

    synthesis rate of selected acute phase proteins

    after intervention

Study Arms (2)

Sulfur Amino Acids

EXPERIMENTAL

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.

Dietary Supplement: sulfur amino acids

Alanine

PLACEBO COMPARATOR

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.

Dietary Supplement: sulfur amino acids

Interventions

sulfur amino acidsDIETARY_SUPPLEMENT

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

AlanineSulfur Amino Acids

Eligibility Criteria

Age6 Months - 18 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
* Infants and toddlers, 6-18 months of age * Suffering from severe protein-energy malnutrition, kwashiorkor and marasmic-kwashiorkor

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Tropical Metabolism Research Unit, University of the West Indies

Kingston, Saint Andrew Parish, Kingston-7, Jamaica

Location

Related Publications (1)

  • 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.

    PMID: 22170355DERIVED

MeSH Terms

Conditions

Protein-Energy MalnutritionKwashiorkor

Interventions

Amino Acids, Sulfur

Condition Hierarchy (Ancestors)

Protein DeficiencyDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesSevere Acute Malnutrition

Intervention Hierarchy (Ancestors)

Sulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Farook Jahoor, Ph.D.

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 15, 2003

First Posted

September 17, 2003

Study Start

June 1, 2003

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

August 1, 2017

Record last verified: 2017-07

Locations

JA(1)