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CompletedNCT00069134Updated Aug 1, 2017

Study of Antioxidants and Oxidants in Malnourished Children

An interventional study of sulfur amino acids in Protein-energy Malnutrition, Kwashiorkor and Marasmus, sponsored by Baylor College of Medicine. Completed at 1 site in Jamaica. Open to participants aged 6 Months to 18 Months. Per ClinicalTrials.gov, last updated 2017-08-01.

Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
6 Months to 18 Months
Sex
All
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Study 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.

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Conditions studied

  • Protein-energy Malnutrition
  • Kwashiorkor
  • Marasmus

Keywords

  • glutathione kinetics
  • oxidant damage
  • anti-oxidant capacity
  • oxidative stress
  • cysteine kinetics
  • severe childhood malnutrition
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In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 86 is close to the median of 90 across 1,135 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 18 Months
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
86 participants (actual)

Study arms

  • Experimental
    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.

    Dietary Supplement: sulfur amino acids

  • Placebo comparator
    Alanine

    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

  • Dietary supplementsulfur amino acids

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: after intervention

  2. immune capacity

    synthesis rate of selected acute phase proteins

    Time frame: after intervention

07

Study locations

1 site
  • Tropical Metabolism Research Unit, University of the West Indies
    Kingston, Saint Andrew Kingston-7, Jamaica
08

References and documents

Publications

  • 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. PubMed 22170355 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00069134
Lead sponsor
Baylor College of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Farook Jahoor (Professor, Baylor College of Medicine) — Principal investigator
First posted
Sep 17, 2003
Start date
Jun 2003
Primary completion
Jan 2016
Completion
Jan 2016
Last update
Aug 1, 2017

Study contacts

Farook Jahoor, Ph.D.
principal investigator · Baylor College of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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