Study of Antioxidants and Oxidants in Malnourished Children

NCT ID: NCT00069134

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2016-01-31

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.

Conditions

Protein-energy Malnutrition; Kwashiorkor; Marasmus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

sulfur amino acids

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: PLACEBO_COMPARATOR

sulfur amino acids

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

sulfur amino acids

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Farook Jahoor

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Farook Jahoor, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Tropical Metabolism Research Unit, University of the West Indies

Kingston, Saint Andrew Parish, Jamaica

Countries

Jamaica

References

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.

Reference Type: DERIVED

PMID: 22170355 (View on PubMed)

Other Identifiers

R01DK056689

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GLUTH - dk56689

Identifier Type: -

Identifier Source: org_study_id