Visceral Leishmaniasis and Malnutrition in Amhara Regional State, Ethiopia

Malnutrition Clinical Trial

— VL&MNEthio  

Official title:

Visceral Leishmaniasis and Malnutrition in Amhara Regional State, Ethiopia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148822
• Other study ID #: Opt1228
• Status: Completed
• Phase: N/A
• First received: May 23, 2014
• Last updated: May 27, 2014
• Start date: December 2009
• Est. completion date: February 2011

Study information

• Verified date: May 2014
• Source: Instituto de Salud Carlos III
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethiopia: Ethical Review Committee
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: February 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 15 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Visceral
• Malnutrition
• Visceral Leishmaniasis

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Instituto de Salud Carlos III	Armauer Hansen Research Institute, Ethiopia, UBS Optimus Foundation

References & Publications (4)

Custodio E, Descalzo MA, Roche J, Molina L, Sánchez I, Lwanga M, Torres AM, Fernández-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 Hu — View Citation

Custodio E, Gadisa E, Sordo L, Cruz I, Moreno J, Nieto J, Chicharro C, Aseffa A, Abraham Z, Hailu T, Cañavate C. Factors associated with Leishmania asymptomatic infection: results from a cross-sectional survey in highland northern Ethiopia. PLoS Negl Trop — View Citation

López-Perea N, Sordo L, Gadisa E, Cruz I, Hailu T, Moreno J, Aseffa A, Cañavate 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 — View Citation

Sordo L, Gadisa E, Custodio E, Cruz I, Simón F, Abraham Z, Moreno J, Aseffa A, Tsegaye H, Nieto J, Chicharro C, Cañavate 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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Growth		December 2009, May 2010 and February 2011 (up to 14 months)	No
Primary	visceral leishmaniasis disease		December 2009, May 2010 and February 2011 (up to 14 months)	No
Secondary	visceral leishmaniasis infection		December 2009, May 2010 and February 2011 (up to 14 months)	No