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CompletedNCT02148822VL&MNEthioUpdated May 28, 2014

Visceral Leishmaniasis and Malnutrition in Amhara Regional State, Ethiopia

An observational study in Visceral Leishmaniasis and Malnutrition, sponsored by Instituto de Salud Carlos III. Completed. Open to participants aged 4 Years to 15 Years. Per ClinicalTrials.gov, last updated 2014-05-28.

Sponsored by Instituto de Salud Carlos III · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
520
Ages
4 Years to 15 Years
Sex
All
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Study 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.

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Conditions studied

  • Visceral Leishmaniasis
  • Malnutrition

Keywords

  • Visceral leishmaniasis
  • kala azar
  • malnutrition
  • stunting
  • thinness
  • Leishmania donovani
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In context

Leishmaniasis

185 studies on the registry are indexed under Leishmaniasis; 15 are open to participants now.

This study's enrollment of 520 is above the median of 224 across 42 observational studies indexed under Leishmaniasis.

Browse Leishmaniasis studies →

Lead sponsor

Instituto de Salud Carlos III is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
520 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. visceral leishmaniasis disease

    Time frame: December 2009, May 2010 and February 2011 (up to 14 months)

Secondary outcomes

  1. visceral leishmaniasis infection

    Time frame: December 2009, May 2010 and February 2011 (up to 14 months)

Other outcomes

  1. Growth

    Time frame: December 2009, May 2010 and February 2011 (up to 14 months)

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Study locations

No study locations are listed for this record.

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References and documents

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 24743328 ↗
  • 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. PubMed 23029576 ↗
  • 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. PubMed 22665599 ↗
  • 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. PubMed 19959405 ↗
  • 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. PubMed 26203904 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02148822
Lead sponsor
Instituto de Salud Carlos III
Collaborators
UBS Optimus Foundation, Armauer Hansen Research Institute, Ethiopia
Responsible party
Estefania Custodio (Researcher, Instituto de Salud Carlos III) — Principal investigator
First posted
May 28, 2014
Start date
Dec 2009
Primary completion
Dec 2009
Completion
Feb 2011
Last update
May 28, 2014

Study contacts

Estefania D Custodio, PhD
study chair · Instituto de Salud Carlos III

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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