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Hyperphenylalaninemia in Cerebral Malaria

NCT00338520 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 285

Last updated 2012-10-22

No results posted yet for this study

Summary

The purpose of this study is to see if children, who develop coma from malaria, are not making enough of a vitamin-like chemical, tetrahydrobiopterin (BH4), which is required for the brain to function normally. This information may help to identify new ways to treat malaria in the future. Study participants will include 512 children, ages 6 months to 6 years. Participants will be placed into one of 4 groups: well children; children with mild malaria; children without malaria, but with a medical problem involving the brain that requires a lumbar puncture for diagnosis (a procedure in which a needle is placed into an area surrounding the spinal cord and a sample of cerebral spinal fluid is removed); and children with a severe form of malaria affecting the brain called cerebral malaria. Study procedures will include blood samples, urine samples and lumbar puncture, only if necessary for diagnosis as part of standard practice procedures. Participants will be involved in study related procedures for up to 3 weeks.

Conditions

  • Plasmodium Falciparum Malaria

Sponsors & Collaborators

  • Hubert Kairuki Memorial University

    collaborator OTHER

  • Duke University

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of Utah

    lead OTHER

Principal Investigators

  • Donald L Granger, M.D. · University of Utah, Division of Infectious Diseases

  • Esther D. Mwaikambo, M.D. · Hubert Kairuki Memorial Hospital (HKMU)

Eligibility

Min Age
6 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Tanzania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00338520 on ClinicalTrials.gov