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Study of Antioxidants and Oxidants in Malnourished Children

Glutathione Homeostasis and Oxidant Damage in Kwashiorkor

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00069134
Enrollment
86
Registered
2003-09-17
Start date
2003-06-30
Completion date
2016-01-31
Last updated
2017-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kwashiorkor, Marasmus, Protein-energy Malnutrition

Keywords

glutathione kinetics, oxidant damage, anti-oxidant capacity, oxidative stress, cysteine kinetics, severe childhood malnutrition

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.

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

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Baylor College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
6 Months to 18 Months
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
small intestine, skin function and red blood cell gluathione synthesisafter interventionThe 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 capacityafter interventionsynthesis rate of selected acute phase proteins

Countries

Jamaica

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026