Clinical Trial: A Community Trial for Visceral Leishmaniasis (VL)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Leishman

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 randomizatio

Detailed Summary:
Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

Current Primary Outcome: 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. [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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. [ Time Frame: 12 months ]

Original Secondary Outcome: Same as current

Information By: International Centre for Diarrhoeal Disease Research, Bangladesh

Dates:
Date Received: February 14, 2010
Date Started: October 2009
Date Completion:
Last Updated: November 12, 2012
Last Verified: January 2010