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NCT Number: NCT03155035

Effect of Routine Deworming on Weight of Children

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.

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Key information

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dow University of Health Sciences

Karachi, Sindh, 74200, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Albendazole

Drug

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

Calcium 400 mg + Vitamin D 2.5 mcg

Dietary Supplement

2 chewable tablets provide recommended daily allowance for calcium and vitamin D

Primary outcomes

  1. Weight

    Time frame: 8 weeks

    Weight of subject in Kgs

  2. MUAC

    Time frame: 8 weeks

    Mid Upper Arm Circumference in cms

  3. TSF

    Time frame: 8 weeks

    Tricep Skin Fold thickness in mms

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 16, 2017
Registry last updated
Jul 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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