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.
Phase:
N/A
Details
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators:
IDRI Nagasaki University
Treatments:
Albendazole Iron Retinol palmitate Vitamin A Vitamins Zinc