A Community Trial for Visceral Leishmaniasis (VL)
Condition: Visceral Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Visceral
Study type: Interventional

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.
    


Intervention name(s): Albendazole, Iron, Zinc and Vitamin A; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 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.; Placebo
Intervention MeSH terms: Vitamin A; Albendazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Visceral leishmaniasis; Kala-azar; Bangladesh; Malnutrition; Asymptomatic; Albendazole; Iron; Zinc; Vitamin A