Visceral LeishmaniasisNCT01069198
A Community Trial for Visceral Leishmaniasis (VL)
A study testing Albendazole, Iron, Zinc and Vitamin A in people with Visceral Leishmaniasis, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 2 sites in Bangladesh.
Trial 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%). Read more about this study
- Who is it for?
- Ages 2 to 60 years
- Conditions the study is for
- Visceral Leishmaniasis
- What is being tested?
- Albendazole, Iron, Zinc and Vitamin A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesBangladesh
- Study dates
- Oct 2009to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- An individual with positive rK39 strip test, without past history of VL and/or symptom and sign of chronic illness.
Who cannot join
- Children aged < 2 years,
- Adults aged > 60 years,
- Patients of active VL,
- Pregnant women,
- People with chronic or debilitating conditions.
Trial locations and contacts
2 sites in 1 country.
Bangladesh2 sites
International Centre For Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh, 1212
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, 1212
About this study
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.
- Conditions
- Visceral Leishmaniasis
- Being tested
- Albendazole, Iron, Zinc and Vitamin A, Placebo
- Keywords
- Visceral leishmaniasis, Kala-azar, Bangladesh, Malnutrition, Asymptomatic, Albendazole, Iron, Zinc, Vitamin A
- Medical subject headings
- Leishmaniasis, Visceral, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albendazole, Iron, Zinc and Vitamin ADrug
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.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Drug: Albendazole, Iron, Zinc and Vitamin A |
| Non-intervention group | Placebo comparator | Non-intervention group will receive placebo following the same schedule as intervention group. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral LeishmaniasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Access to Advanced Health Institute (AAHI), Nagasaki University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069198
- Sponsor's protocol ID
- PR-09018
- Status last verified
- Jan 2010
- First submitted
- 14 Feb 2010
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01069198
- Acronym / sponsor ID
- PR-09018
- Conditions
- Visceral Leishmaniasis
- Keywords
- Visceral leishmaniasis, Kala-azar, Bangladesh, Malnutrition, Asymptomatic, Albendazole, Iron, Zinc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- Access to Advanced Health Institute (AAHI), Nagasaki University
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Albendazole, Iron, Zinc and Vitamin A |
| Non-intervention group | Placebo comparator | Other: PlaceboNon-intervention group will receive placebo following the same schedule as intervention group. |
Who may qualify
- Ages
- 2 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- An individual with positive rK39 strip test, without past history of VL and/or symptom and sign of chronic illness.
Key exclusion criteria (5 listed)
- Children aged < 2 years,
- Adults aged > 60 years,
- Patients of active VL,
- Pregnant women,
- People with chronic or debilitating conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albendazole, Iron, Zinc and Vitamin Asingle 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. | Drug | Intervention group |
| PlaceboPlacebo | Other | Non-intervention group |
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
1 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albendazole, Iron, Zinc and Vitamin A in people with Visceral Leishmaniasis, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 2 sites in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2012.