Relative Efficacy of Two Regimens of Ante-helminthic Treatment

NCT00367627 | Completed

• 1 other identifier: 2006-026
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Helminthiasis

Keywords

Children; Malnutrition; Ascaris Lumbricoides; Trichuris trichiura Morbidity; Helminthiasis; Children 2-5 years; Stool RME +ve for helminthiasis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Albendazole DRUG

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

ICDDR,B: Centre for Health and Population Research

Dhaka, 1212, Bangladesh

Location

MeSH Terms

Conditions

Helminthiasis; Malnutrition

Interventions

Albendazole

Condition Hierarchy (Ancestors)

Parasitic Diseases; Infections; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mohammad M Alam, MBBS

  ICDDR,B: Centre for Health and Population Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 22, 2006
• First Posted: August 23, 2006
• Study Start: December 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: July 12, 2011

Record last verified: 2006-08

Locations

BA (1)