Visceral Leishmaniasis and Malnutrition in Amhara Regional State, Ethiopia

NCT02148822 | Completed

• 1 other identifier: Opt1228
• Study Type: observational
• Target: 520
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Visceral Leishmaniasis; Malnutrition

Keywords

Visceral leishmaniasis; kala azar; malnutrition; stunting; thinness; Leishmania donovani

Outcome Measures

Primary Outcomes (1)

• visceral leishmaniasis disease

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

Secondary Outcomes (1)

• visceral leishmaniasis infection

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

Other Outcomes (1)

• Growth

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

Study Arms (2)

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.

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Salud Carlos III: lead
• UBS Optimus Foundation: collaborator
• Armauer Hansen Research Institute, Ethiopia: collaborator

Related Publications (5)

• 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.

  PMID: 24743328 RESULT

• 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.

  PMID: 23029576 RESULT

• 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.

  PMID: 22665599 RESULT

• 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.

  PMID: 19959405 RESULT

• 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.

  PMID: 26203904 DERIVED

MeSH Terms

Conditions

Leishmaniasis, Visceral; Malnutrition; Growth Disorders; Thinness

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Weight; Signs and Symptoms

Study Officials

• Estefania D Custodio, PhD

  Instituto de Salud Carlos III

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: May 23, 2014
• First Posted: May 28, 2014
• Study Start: December 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2011
• Last Updated: May 28, 2014

Record last verified: 2014-05