Visceral Leishmaniasis Clinical Trial
Official title:
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
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | November 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 60 Years |
Eligibility |
Inclusion Criteria: - An individual with positive rK39 strip test, without past history of VL and/or symptom and sign of chronic illness. Exclusion Criteria: - Children aged < 2 years, - Adults aged > 60 years, - Patients of active VL, - Pregnant women, - People with chronic or debilitating conditions. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Bangladesh | International Centre for Diarrhoeal Disease Research, Bangladesh | Dhaka |
Lead Sponsor | Collaborator |
---|---|
International Centre for Diarrhoeal Disease Research, Bangladesh | IDRI, Nagasaki University |
Bangladesh,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | 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 | No |
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