KwashiorkorNCT00429351
Aromatic Amino Acid Metabolism in the Pathogenesis of Kwashiorkor
An observational study of Kwashiorkor, run by Baylor College of Medicine at 1 site in Jamaica.
Trial summary
This research may explain whether a shortage of three special compounds called aromatic amino acids is responsible for the severe illness and high death rate of children with the kwashiorkor type of malnutrition and whether supplying adequate amounts of these compounds in the treatment diet will speed up recovery from… Read more about this study
- Who is it for?
- Ages 6 to 18 months
- Conditions the study is for
- Kwashiorkor
- How many people
- 82 participants
- Where
- 1 siteJamaica
- Study dates
- Sep 2006to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 months
- All sexes
- No healthy volunteers
- Child
Study population: 82 children aged 6 to 18 months and diagnosed with severe protein-energy malnutrition. By the Wellcome Classification patients will have marasmus (< 60 % weight/age and no edema), marasmic-kwashiorkor (< 60 % weight/age plus edema) or kwashiorkor (< 80 % weight/age plus edema)
Who may be able to join
- Malnourished children between 6 to 18 months of age.
- To standardize for degree of malnutrition, only patients whose weight is < 80 % of that expected for age will be enrolled. By the Wellcome Classification (22), enrolled patients will have marasmus (< 60 % weight/age and no edema), marasmic-kwashiorkor (< 60 % weight/age plus edema) or kwashiorkor (< 80 % weight/age plus edema).
- Presence of infection at admission. Infection will be defined by the presence of two or more of the following: Leukocyte count >11,000 cells/dl, temperature at admission > 99 oF, positive blood or urine cultures.
Who cannot join
- Criteria for exclusion will include presence of cardiovascular, hepatic, renal, gastrointestinal, metabolic disease or HIV/AIDS.
Trial locations and contacts
1 site in 1 country.
Jamaica1 site
Tropical Metabolism Research Unit, University of the West Indies
Mona, Kingston, Kingston-7
About this study
This research may explain whether a shortage of three special compounds called aromatic amino acids is responsible for the severe illness and high death rate of children with the kwashiorkor type of malnutrition and whether supplying adequate amounts of these compounds in the treatment diet will speed up recovery from this condition. We propose that decreased availability of the aromatic amino acids may be the reason why children with kwashiorkor are sicker and more difficult to treat.
- Conditions
- Kwashiorkor
- Medical subject headings
- Kwashiorkor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2007 (estimated)
- Study startSep 2006
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KwashiorkorStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farook Jahoor, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429351
- Sponsor's protocol ID
- H-16233
- Other IDs
- R01DK075018
- Status last verified
- Feb 2020
- First submitted
- 30 Jan 2007
- Last updated
- 26 Feb 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatic Amino Acid Metabolism in the Pathogenesis of Kwashiorkor
- ClinicalTrials.gov ID
- NCT00429351
- Acronym / sponsor ID
- H-16233
- Conditions
- Kwashiorkor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2006
- Study completion
- Jun 2010 (actual)
- First posted
- 31 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research may explain whether a shortage of three special compounds called aromatic amino acids is responsible for the severe illness and high death rate of children with the kwashiorkor type of malnutrition and whether supplying adequate amounts of these compounds in the treatment diet will speed up recovery from this condition. We propose that decreased availability of the aromatic amino acids may be the reason why children with kwashiorkor are sicker and more difficult to treat.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 82 children aged 6 to 18 months and diagnosed with severe protein-energy malnutrition. By the Wellcome Classification patients will have marasmus (< 60 % weight/age and no edema), marasmic-kwashiorkor (< 60 % weight/age plus edema) or kwashiorkor (< 80 % weight/age plus edema)
Key inclusion criteria (3 listed)
- Malnourished children between 6 to 18 months of age.
- To standardize for degree of malnutrition, only patients whose weight is < 80 % of that expected for age will be enrolled. By the Wellcome Classification (22), enrolled patients will have marasmus (< 60 % weight/age and no edema), marasmic-kwashiorkor (< 60 % weight/age plus edema) or kwashiorkor (< 80 % weight/age plus edema).
- Presence of infection at admission. Infection will be defined by the presence of two or more of the following: Leukocyte count >11,000 cells/dl, temperature at admission > 99 oF, positive blood or urine cultures.
Key exclusion criteria (1 listed)
- Criteria for exclusion will include presence of cardiovascular, hepatic, renal, gastrointestinal, metabolic disease or HIV/AIDS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kwashiorkor, run by Baylor College of Medicine at 1 site in Jamaica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jamaica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.