Visceral LeishmaniasisVL&MNEthioNCT02148822
Visceral Leishmaniasis and Malnutrition in Amhara Regional State, Ethiopia
An observational study of Visceral Leishmaniasis and Malnutrition, run by Instituto de Salud Carlos III.
Trial summary
The project Visceral Leishmaniasis and Malnutrition is a cohort study that aimed to assess the association between malnutrition and visceral leishmaniasis (VL). It was conducted in Libo Kemkem and Fogera districts of the Amhara Regional State in Ethiopia. Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Visceral Leishmaniasis, Malnutrition
- How many people
- 520 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Feb 2011
- 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 4 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: School age children from VL high prevalent communities of Libo Kemkem and Fogera districts in Amhara Regional State, Ethiopia
Who may be able to join
- Reported age between 4 and 15 years of age
- Currently living in the selected household
Who cannot join
- To be ill of visceral leishmaniasis at the time of the survey
- To be positive to visceral leishmaniasis infection tests at the time of the first survey
- To be under treatment for visceral leishmaniasis at the time of the survey
- To be extremely ill of any other condition
About this study
The project Visceral Leishmaniasis and Malnutrition is a cohort study that aimed to assess the association between malnutrition and visceral leishmaniasis (VL). It was conducted in Libo Kemkem and Fogera districts of the Amhara Regional State in Ethiopia. Clinical, anthropometric, biochemical, immunological, parasitological and sociodemographic data of school age children from VL high prevalence communities were collected in December 2009, May 2010 and February 2011.
- Conditions
- Visceral Leishmaniasis, Malnutrition
- Keywords
- Visceral leishmaniasis, kala azar, malnutrition, stunting, thinness, Leishmania donovani
- Medical subject headings
- Leishmaniasis, Visceral, Malnutrition, Growth Disorders, Thinness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Malnourished | Children with either height for age z score or body mass index for age z score below 2 standard deviations according to the World Health Organization Growth Standards for children younger than 5 years and the 2007 WHO Growth Reference for children of 5 years or older. | |
| Not malnourished | Children with either height for age z score or body mass index for age z score equal or higher than 2 standard deviations according to the World Health Organization Growth Standards for children younger than 5 years and the 2007 WHO Growth Reference for children of 5 years or older. |
What is being measured
The primary outcome is the main question the study is designed to answer.
visceral leishmaniasis disease
Measured: December 2009, May 2010 and February 2011 (up to 14 months)
Secondary outcomes (1)
visceral leishmaniasis infection
Measured: December 2009, May 2010 and February 2011 (up to 14 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startDec 2009
- Primary completionDec 2009
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Visceral LeishmaniasisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Salud Carlos III
- Sponsor type
- Other government
- Collaborators
- UBS Optimus Foundation, Armauer Hansen Research Institute, Ethiopia
- Responsible party
- Principal investigator, Estefania Custodio, Instituto de Salud Carlos III
- Investigators
- Estefania D Custodio, PhD, Study chair, Instituto de Salud Carlos III
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148822
- Sponsor's protocol ID
- Opt1228
- Acronym
- VL&MNEthio
- Status last verified
- May 2014
- First submitted
- 23 May 2014
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lopez-Perea N, Sordo L, Gadisa E, Cruz I, Hailu T, Moreno J, Aseffa A, Canavate C, Custodio E. Knowledge, attitudes and practices related to visceral leishmaniasis in rural communities of Amhara State: a longitudinal study in northwest Ethiopia. PLoS Negl Trop Dis. 2014 Apr 17;8(4):e2799. doi: 10.1371/journal.pntd.0002799. eCollection 2014 Apr.
PubMed 24743328Custodio E, Gadisa E, Sordo L, Cruz I, Moreno J, Nieto J, Chicharro C, Aseffa A, Abraham Z, Hailu T, Canavate C. Factors associated with Leishmania asymptomatic infection: results from a cross-sectional survey in highland northern Ethiopia. PLoS Negl Trop Dis. 2012;6(9):e1813. doi: 10.1371/journal.pntd.0001813. Epub 2012 Sep 27.
PubMed 23029576Sordo L, Gadisa E, Custodio E, Cruz I, Simon F, Abraham Z, Moreno J, Aseffa A, Tsegaye H, Nieto J, Chicharro C, Canavate C. Low prevalence of Leishmania infection in post-epidemic areas of Libo Kemkem, Ethiopia. Am J Trop Med Hyg. 2012 Jun;86(6):955-8. doi: 10.4269/ajtmh.2012.11-0436.
PubMed 22665599Custodio E, Descalzo MA, Roche J, Molina L, Sanchez I, Lwanga M, Torres AM, Fernandez-Zincke E, Bernis C, Villamor E, Baylin A. The economic and nutrition transition in Equatorial Guinea coincided with a double burden of over- and under nutrition. Econ Hum Biol. 2010 Mar;8(1):80-7. doi: 10.1016/j.ehb.2009.10.001. Epub 2009 Oct 31.
PubMed 19959405Herrador Z, Perez-Formigo J, Sordo L, Gadisa E, Moreno J, Benito A, Aseffa A, Custodio E. Low Dietary Diversity and Intake of Animal Source Foods among School Aged Children in Libo Kemkem and Fogera Districts, Ethiopia. PLoS One. 2015 Jul 23;10(7):e0133435. doi: 10.1371/journal.pone.0133435. eCollection 2015.
PubMed 26203904
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visceral Leishmaniasis and Malnutrition in Amhara Regional State, Ethiopia
- ClinicalTrials.gov ID
- NCT02148822
- Acronym / sponsor ID
- VL&MNEthio / Opt1228
- Conditions
- Visceral Leishmaniasis, Malnutrition
- Keywords
- Visceral leishmaniasis, kala azar, malnutrition, stunting, thinness, Leishmania donovani
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Instituto de Salud Carlos IIIOther government
- Collaborators
- UBS Optimus Foundation, Armauer Hansen Research Institute, Ethiopia
- Study start
- Dec 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 28 May 2014 (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.
The project Visceral Leishmaniasis and Malnutrition is a cohort study that aimed to assess the association between malnutrition and visceral leishmaniasis (VL). It was conducted in Libo Kemkem and Fogera districts of the Amhara Regional State in Ethiopia. Clinical, anthropometric, biochemical, immunological, parasitological and sociodemographic data of school age children from VL high prevalence communities were collected in December 2009, May 2010 and February 2011.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Malnourished | – | –Children with either height for age z score or body mass index for age z score below 2 standard deviations according to the World Health Organization Growth Standards for children younger than 5 years and the 2007 WHO Growth Reference for children of 5 years or older. |
| Not malnourished | – | –Children with either height for age z score or body mass index for age z score equal or higher than 2 standard deviations according to the World Health Organization Growth Standards for children younger than 5 years and the 2007 WHO Growth Reference for children of 5 years or older. |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- School age children from VL high prevalent communities of Libo Kemkem and Fogera districts in Amhara Regional State, Ethiopia
Key inclusion criteria (2 listed)
- Reported age between 4 and 15 years of age
- Currently living in the selected household
Key exclusion criteria (4 listed)
- To be ill of visceral leishmaniasis at the time of the survey
- To be positive to visceral leishmaniasis infection tests at the time of the first survey
- To be under treatment for visceral leishmaniasis at the time of the survey
- To be extremely ill of any other condition
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
visceral leishmaniasis disease
Time frame: December 2009, May 2010 and February 2011 (up to 14 months)
1 secondary outcome
visceral leishmaniasis infection
Time frame: December 2009, May 2010 and February 2011 (up to 14 months)
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 28 May 2014.
- Results publication: PubMed 24743328Lopez-Perea N, Sordo L, Gadisa E, Cruz I, Hailu T, Moreno J, Aseffa A, Canavate C, Custodio E. Knowledge, attitudes and practices related to visceral leishmaniasis in rural communities of Amhara State: a longitudinal study in northwest Ethiopia. PLoS Negl Trop Dis. 2014 Apr 17;8(4):e2799. doi: 10.1371/journal.pntd.0002799. eCollection 2014 Apr.
- Results publication: PubMed 23029576Custodio E, Gadisa E, Sordo L, Cruz I, Moreno J, Nieto J, Chicharro C, Aseffa A, Abraham Z, Hailu T, Canavate C. Factors associated with Leishmania asymptomatic infection: results from a cross-sectional survey in highland northern Ethiopia. PLoS Negl Trop Dis. 2012;6(9):e1813. doi: 10.1371/journal.pntd.0001813. Epub 2012 Sep 27.
- Results publication: PubMed 22665599Sordo L, Gadisa E, Custodio E, Cruz I, Simon F, Abraham Z, Moreno J, Aseffa A, Tsegaye H, Nieto J, Chicharro C, Canavate C. Low prevalence of Leishmania infection in post-epidemic areas of Libo Kemkem, Ethiopia. Am J Trop Med Hyg. 2012 Jun;86(6):955-8. doi: 10.4269/ajtmh.2012.11-0436.
- Results publication: PubMed 19959405Custodio E, Descalzo MA, Roche J, Molina L, Sanchez I, Lwanga M, Torres AM, Fernandez-Zincke E, Bernis C, Villamor E, Baylin A. The economic and nutrition transition in Equatorial Guinea coincided with a double burden of over- and under nutrition. Econ Hum Biol. 2010 Mar;8(1):80-7. doi: 10.1016/j.ehb.2009.10.001. Epub 2009 Oct 31.
- Derived from this study: PubMed 26203904Herrador Z, Perez-Formigo J, Sordo L, Gadisa E, Moreno J, Benito A, Aseffa A, Custodio E. Low Dietary Diversity and Intake of Animal Source Foods among School Aged Children in Libo Kemkem and Fogera Districts, Ethiopia. PLoS One. 2015 Jul 23;10(7):e0133435. doi: 10.1371/journal.pone.0133435. eCollection 2015.
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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.
Estefania D Custodio, PhD study chair
Instituto de Salud Carlos III
Questions about this trial
What is this clinical trial studying?
An observational study of Visceral Leishmaniasis and Malnutrition, run by Instituto de Salud Carlos III.
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 2 inclusion and 4 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 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
visceral leishmaniasis disease (time frame: December 2009, May 2010 and February 2011 (up to 14 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02148822, which also lists 5 linked publications.
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 28 May 2014.