A Community Trial for Visceral Leishmaniasis (VL)
A Randomized, Double Blind, Community Trial to Assess the Efficacy of a Combination of Anti-helminth, and Vitamin A, Zinc and Iron Supplementation in Preventing Visceral Leishmaniasis (VL) Disease Among Asymptomatic Individuals With VL
1 other identifier
interventional
200
1 country
2
Brief Summary
Visceral leishmaniasis (VL) / Kala-azar (KA) is a public health problem in the many countries in the world including Bangladesh. Where more than 90,000 VL cases have been reported since 1994. The disease is fatal if not treated. Even with treatment the mortality rate is high (10%). VL is a vector-borne disease, caused by the parasite Leishmania donovani (LD) and is transmitted by female sandfly sp. Phlebotomus argentipes. Not all people exposed to the LD parasite develop disease. According to our observation only about 30% of the infected with LD parasite develop disease within one year of diagnosis. Malnutrition and intestinal helminth infection have been found to be associated with the risk of active VL. Down regulation of Th1 cellular immune response confers susceptibility to active VL. Both malnutrition and intestinal helminth infection down regulate the Th1 cellular immune response. Till now there is no established prophylaxis against active VL among the people exposed to the LD infection. Many studies including ours have been shown that periodic regular deworming reduced malnutrition significantly. Micronutrient such as zinc and iron as well vitamin A supplementation also improve malnutrition and may enhance Th1 cellular immune response. Thus we hypothesize that periodic deworming and. micronutrient and vitamin A supplementation together may reduce the risk of active VL among the people exposed to the LD infection. The study will be carried out in the Harirampur union, Trishal, Mymensingh. This area is highly endemic for VL. Two hundred asymptomatic VL patients aged 2-60 will be enrolled to the study. Children aged less than 2 years, pregnant women, active VL case, person with chronic disease, disable individuals and those who will refuse written consent will not be enrolled to the study. After enrollment subjects will be divided into two groups through randomization. One group will receive deworming and nutritional supplement (intervention group) and other group will receive placebo (placebo group). Two groups will be followed for 12 months through active surveillance for developing of active VL. In addition morbidity data, monthly stool sampling, monthly anthropometry, urine and blood sampling at baseline, before and after treatment of active VL will be carried out Successful completion of the study and derived results from it will provide useful information that whether periodic deworming with micronutrient and vitamin A supplementation can reduce the risk of active VL among the people exposed to the LD infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 14, 2010
CompletedFirst Posted
Study publicly available on registry
February 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedNovember 14, 2012
January 1, 2010
1 year
February 14, 2010
November 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the effect of deworming and supplementation with iron, zinc and vitamin A on incidence of active VL among the individuals with asymptomatic VL.
12 months
Secondary Outcomes (1)
To investigate the prevalence of asymptomatic and symptomatic VL among the households with a past case of VL. To measure the parasite load in the blood by Real Time PCR and to study the association of blood parasite load with active VL.
12 months
Study Arms (2)
Intervention group
EXPERIMENTALNon-intervention group
PLACEBO COMPARATORNon-intervention group will receive placebo following the same schedule as intervention group.
Interventions
single oral dose of 200,000 IU Vitamin A at baseline and after six months, 35 mg and 65 oral elemental iron for subject aged \<5 and \>=5 years respectively everyday for two months starting from enrollment; 10 mg oral zinc for 10 consecutive days each month for 6 months; and a single 400 mg oral dose of albendazole at 3-months' intervals.
Eligibility Criteria
You may qualify if:
- An individual with positive rK39 strip test, without past history of VL and/or symptom and sign of chronic illness.
You may not qualify if:
- Children aged \< 2 years,
- Adults aged \> 60 years,
- Patients of active VL,
- Pregnant women,
- People with chronic or debilitating conditions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
International Centre For Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh, 1212, Bangladesh
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, 1212, Bangladesh
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2010
First Posted
February 17, 2010
Study Start
October 1, 2009
Primary Completion
October 1, 2010
Study Completion
November 1, 2010
Last Updated
November 14, 2012
Record last verified: 2010-01