Visceral Leishmaniasis and Malnutrition in Amhara Regional State, Ethiopia (VL&MNEthio)

May 27, 2014 updated by: Estefania Custodio, Instituto de Salud Carlos III
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

520

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
visceral leishmaniasis disease
Time Frame: December 2009, May 2010 and February 2011 (up to 14 months)
December 2009, May 2010 and February 2011 (up to 14 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
visceral leishmaniasis infection
Time Frame: December 2009, May 2010 and February 2011 (up to 14 months)
December 2009, May 2010 and February 2011 (up to 14 months)

Other Outcome Measures

Outcome Measure
Time Frame
Growth
Time Frame: December 2009, May 2010 and February 2011 (up to 14 months)
December 2009, May 2010 and February 2011 (up to 14 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Salud Carlos III

Collaborators

UBS Optimus Foundation
Armauer Hansen Research Institute, Ethiopia

Investigators

  • Study Chair: Estefania D Custodio, PhD, Instituto de Salud Carlos III

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

May 23, 2014

First Submitted That Met QC Criteria

May 27, 2014

First Posted (Estimate)

May 28, 2014

Study Record Updates

Last Update Posted (Estimate)

May 28, 2014

Last Update Submitted That Met QC Criteria

May 27, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Opt1228

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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