Study of Antioxidants and Oxidants in Malnourished Children

Baylor College of Medicine

Status: Completed

Conditions: Protein-energy Malnutrition; Kwashiorkor; Marasmus

Treatments: Dietary Supplement: sulfur amino acids

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00069134

R01DK056689 (U.S. NIH Grant/Contract)

GLUTH - dk56689

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 6 to 18 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 2 patient groups, including a placebo group

Sulfur Amino Acids

Experimental group

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.

Treatment:

Dietary Supplement: sulfur amino acids

Alanine

Placebo Comparator group

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.

Treatment:

Dietary Supplement: sulfur amino acids