A Community Trial for Visceral Leishmaniasis (VL)

This study has been completed.
Sponsor:
Collaborators:
Infectious Disease Research Institute
Nagasaki University
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT01069198
First received: February 14, 2010
Last updated: November 12, 2012
Last verified: January 2010
  Purpose

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.


Condition Intervention
Visceral Leishmaniasis
Drug: Albendazole, Iron, Zinc and Vitamin A
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: October 2009
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention group Drug: Albendazole, Iron, Zinc and Vitamin A
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 Comparator: Non-intervention group
Non-intervention group will receive placebo following the same schedule as intervention group.
Other: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   2 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069198

Locations
Bangladesh
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Infectious Disease Research Institute
Nagasaki University
  More Information

No publications provided

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01069198     History of Changes
Other Study ID Numbers: PR-09018
Study First Received: February 14, 2010
Last Updated: November 12, 2012
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Visceral leishmaniasis
Kala-azar
Bangladesh
Malnutrition
Asymptomatic
Albendazole
Iron
Zinc
Vitamin A

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Visceral
Euglenozoa Infections
Parasitic Diseases
Protozoan Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Parasitic
Albendazole
Retinol palmitate
Vitamin A
Vitamins
Anthelmintics
Anti-Infective Agents
Anticarcinogenic Agents
Anticestodal Agents
Antimitotic Agents
Antineoplastic Agents
Antioxidants
Antiparasitic Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Growth Substances
Micronutrients
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014