Relative Efficacy of Two Regimens of Ante-helminthic Treatment

This study has been completed.
Sponsor:
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT00367627
First received: August 22, 2006
Last updated: July 11, 2011
Last verified: August 2006
  Purpose

The most common soil transmitted helminthic infections(STHI) includes infection with Ascaris lumbricoides, Trichuris trichiura, and Hookworm. Growth retardation, malnutrition, anemia, impaired cognitive function and immunosuppression are main manifestations in children. Even within the developing world, wide differences exist in prevalence rates. The poorest countries have higher levels of STHI than those with a lower incidence of poverty. According to an estimate made by the WHO, the prevalence of A. lumbricoides, T. trichiura and Hookworm in South Asia was 27%, 20% and 16% respectively. Given that the prevalence of STHI in urban slums in Bangladesh is much higher than the other parts of the world and Asia and that there are major health and socio-economic consequences of such infections, it is important that we come up with effective means of reducing the prevalence of such infections. 60-80% of preschool children in urban slums of Bangladesh are infected with these STHI due to poor hygiene . At present deworming at six months interval is recommended but the effectiveness of this regimen of dewormig is questionable.

2. Hypothesis: Ante-helminthic treatment at every three month is more effective than ante-helminthic treatment at every six months to reduce soil transmitted helminthic infection, to reduce diarrheal and respiratory illness to improve nutritional status in preschool children.

3.Objective: The main objectives of the proposed study is to compare the relative efficacy of two different ante-helminthic treatment regimens to reduce the prevalence of STHI, diarrheal diseases, respiratory illness and to improve nutritional status in children 4. Design: The population of the study will be preschool children aged 2-5 year and will be selected randomly from an urban of Dhaka. They will be divided into two groups randomly. One group will get ante-helminthic at every three months interval and the other groups will get at six months interval for one year. Stool samples will be collected at the baseline and after three months completing one-year treatment of the above mentioned regimen. Blood haemoglobulin and nutritional status will also be measured at baseline and after three months of completion of treatment as mentioned above. The treatment will be 400 mg of Albendazole in a single dose.

5. Potential Impact: The findings of the research can be implemented by the government and non-government organization.


Condition Intervention
Helminthiasis
Drug: Albendazole

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To determine the relative efficacy of de-worming at every three months vs. every six month single dose of Albendazole treatment.

Secondary Outcome Measures:
  • To compare additional morbidity information such as diarrheal diseases, respiratory tract infections, nutritional status and E. histolytica associated morbidity between two groups.

Estimated Enrollment: 200
Study Start Date: December 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:The inclusion criteria are;

  1. age of the child is 2-5 years old,
  2. he/she has not been suffering from serious chronic illness,
  3. the child stool test must be positive for STH,
  4. he/she had not been taken any antehelminthic drug in the previous six months,
  5. parents/guardian are agree for their child participation in the study. e -

Exclusion Criteria:

  1. age of the child less than 2 years old and more than 5 years old,
  2. his/her stool test negative for any intestinal helminth,
  3. he/she has been suffering from serious chronic illness,
  4. parents/guardian are not willing to give consent for their child's participation in the study,
  5. if he/she receives any antehelminthic drug after survey but before the study interventions.
  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: NCT00367627

Locations
Bangladesh
ICDDR,B: Centre for Health and Population Research
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
Principal Investigator: Mohammad M Alam, MBBS ICDDR,B: Centre for Health and Population Research
  More Information

No publications provided

Responsible Party: Principal Investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT00367627     History of Changes
Other Study ID Numbers: 2006-026
Study First Received: August 22, 2006
Last Updated: July 11, 2011
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Children
Malnutrition
Ascaris Lumbricoides
Trichuris trichiura Morbidity
Helminthiasis
Children 2-5 years
Stool RME +ve for helminthiasis

Additional relevant MeSH terms:
Helminthiasis
Parasitic Diseases

ClinicalTrials.gov processed this record on October 20, 2014