Effect of Routine Deworming on Weight of Children

Soil Transmitted Helminths Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03155035
• Other study ID #: IRB-816/DUHS/Approval/2016/351
• Status: Completed
• Phase: N/A
• First received: May 14, 2017
• Last updated: July 11, 2017
• Start date: March 7, 2017
• Est. completion date: June 6, 2017

Study information

• Verified date: July 2017
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 6, 2017
• Est. primary completion date: June 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Acutely ill

• Previous deworming dose < 6 months ago

• Intellectually challenged or physical condition interfering with measurement of primary outcome variables

Related Conditions & MeSH terms

• Soil Transmitted Helminths

Intervention

Drug:
• Albendazole
Albendazole 400 mg chewable tablets (200 mg each) Two tablets as a single dose recommended as ovicidal, larvicidal and vermicidal against all soil transmitted helminths

Dietary Supplement:
• Calcium 400 mg + Vitamin D 2.5 mcg
2 chewable tablets provide recommended daily allowance for calcium and vitamin D

Locations

Country	Name	City	State
Pakistan	Dow University of Health Sciences	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Weight of subject in Kgs	8 weeks
Primary	MUAC	Mid Upper Arm Circumference in cms	8 weeks
Primary	TSF	Tricep Skin Fold thickness in mms	8 weeks