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临床试验/NCT03155035
NCT03155035已完成不适用

Effect of Routine Deworming on Weight of Children 5-16 Years Old in an Urban Slum of Karachi: a Randomized Controlled Trial

Dow University of Health Sciences1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年3月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
Weight

研究概览

简要总结

Soil Transmitted Helminths (STH) are among the most common infections in the world today. The World Health Organization (WHO) recommends mass administration of deworming medicine as a single routine annual dose to all school age children (SAC)(age 5-16 years) in countries where prevalence of Soil Transmitted Helminthic Infections (STHI) is > 20% as a safe public health intervention that promotes healthy growth (Category 2 Recommendation). Pakistan is classified as a low burden community with a reported prevalence of STHI <50%, however,routine deworming is not a policy in Pakistan. Currently, Pakistan is also facing a huge burden of malnutrition in all age groups especially in population belonging to low socioeconomic group. Incidentally, worm infestation by STH also occurs in this group due to associated lack of hygiene and poor living conditions. The coexistence of even moderate STH infections can cause or aggravate malnutrition. The urban slums of Karachi provide environmental, social and behavioral conditions that favor both STH infections and a risk of under nutrition. It is unknown if administering routine dose of deworming medicine to SAC as per WHO recommendation will contribute to improvement in indicators of nutrition status in Pakistani children living in urban slum conditions by eliminating worm infection.Therefore, this study is being conducted to determine the effect of deworming on weight of School Age Children aged between 5 to 16 years.

详细描述

A randomized control trial will be conducted in an urban slum of Karachi. Eligible 5 to 16 year old school age children will be enrolled after parental consent. The calculated total sample size is n= 258. Subjects will be visited at home by researcher and background information, risk factor presence and baseline measurements of weight, Mid Upper Arm Circumference (MUAC) and tricep skinfold thickness (TSF) will be measured. The intervention arm will be administered a single dose of chewable Albendazole 400 mg and the placebo arm will receive 400 mg chewable calcium tablets. The weight, MUAC and TSF will be measured again after 8 weeks to determine the change if any. The selection of locality and allocation of intervention will be done using simple random sampling and computer generated random numbers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
5 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Aged 5 - 16 years, Healthy, Able to chew/swallow tablets

排除标准

  • Acutely ill
  • Previous deworming dose < 6 months ago
  • Intellectually challenged or physical condition interfering with measurement of primary outcome variables

研究组 & 干预措施

Intervention

Experimental

Albendazole 200 mg 2 tablets single dose

干预措施: Albendazole (Drug)

Placebo

Placebo Comparator

Calcium 400 mg + vitamin D 2.5 mcg 2 tablets single dose

干预措施: Calcium 400 mg + Vitamin D 2.5 mcg (Dietary Supplement)

结局指标

主要结局

Weight

时间窗: 8 weeks

Weight of subject in Kgs

MUAC

时间窗: 8 weeks

Mid Upper Arm Circumference in cms

TSF

时间窗: 8 weeks

Tricep Skin Fold thickness in mms

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zainab Hasan

Principal Investigator

Dow University of Health Sciences

研究点 (1)

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