Clinical trial NCT02148822: Visceral Leishmaniasis and Malnutrition in Amhara Regional State, Ethiopia
Official title: Visceral Leishmaniasis and Malnutrition in Amhara Regional State, Ethiopia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visceral Leishmaniasis
Malnutrition
Keywords: Visceral leishmaniasis
kala azar
malnutrition
stunting
thinness
Leishmania donovani
Lead sponsor: Instituto de Salud Carlos III
Sponsor class: OTHER_GOV
Collaborators: name: UBS Optimus Foundation
name: Armauer Hansen Research Institute, Ethiopia
First posted: 2014-05-28
Enrollment: 520
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: School age children from VL high prevalent communities of Libo Kemkem and Fogera districts in Amhara Regional State, Ethiopia

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Reported age between 4 and 15 years of age
* Currently living in the selected household

Exclusion Criteria:

* 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

Primary outcomes:
measure: visceral leishmaniasis disease
timeFrame: December 2009, May 2010 and February 2011 (up to 14 months)
Secondary outcomes:
measure: visceral leishmaniasis infection
timeFrame: December 2009, May 2010 and February 2011 (up to 14 months)
Other outcomes:
measure: Growth
timeFrame: December 2009, May 2010 and February 2011 (up to 14 months)
Locations:
Study officials:
affiliation: Instituto de Salud Carlos III
name: Estefania D Custodio, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: Custodio 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.
citation: Sordo 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.
citation: Custodio 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.
citation: Herrador 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.