Relative Efficacy of Two Regimens of Ante-helminthic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- To determine the relative efficacy of de-worming at every three months vs. every six month single dose of Albendazole treatment.
研究概览
简要总结
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.
详细描述
Study design and population:
The study population will be the children aged 2-5 years old in the study area. All children aged 2-5 years old in one slums of the study area will be listed and will be invited to participate in the study.
Parents will be explained the purpose of the study and will be asked for written consent for participation of their children in the study. If the parents give the consent then a stool pot will be given to them to collect stool samples for microscopic examination for intestinal parasites. 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. The exclusion criteria are; 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. The survey will be done in the first months of the study, and then children will be enrolled according to above mentioned inclusion/exclusion criteria. During screening if any child is found severely malnourished it will be considered as'danger sign' according to WHO and IMCI guideline he/she will be referred to an appropriate facility even if she/he is not enrolled in the study. Simple randomization technique will be applied to divide the children into two groups: A) Conventional treatment group who will receive anti-helminthic treatment 400 mg of Albendazole in a single dose at six month interval and B) Intervention group, who will receive anti-helminthic 400 mg of Albendazole in a single dose treatment at three months interval. Stool samples will be collected from both groups prior to anti-helminthic therapy and will be examined quantitatively. However stool examination will not be carried out for intestinal parasite after giving 400 mg of Albendazole at 12 months.
Sample size calculation:
Sample size has been calculated using different predicted values of different out come variables and is shown in the Table 1. A sample size of 200 children, 100 in each group will be sufficient for the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria are;
- •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 -
排除标准
- •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.
结局指标
主要结局
To determine the relative efficacy of de-worming at every three months vs. every six month single dose of Albendazole treatment.
次要结局
- To compare additional morbidity information such as diarrheal diseases, respiratory tract infections, nutritional status and E. histolytica associated morbidity between two groups.