Effect of Routine Deworming on Weight of Children

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

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.

Study Overview

• Status: Completed
• Conditions: Soil Transmitted Helminths
• Intervention / Treatment: Drug: Albendazole; Dietary supplement: Calcium 400 mg + Vitamin D 2.5 mcg

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74200
      • Dow University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Albendazole 200 mg 2 tablets single dose	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
Placebo Comparator: Placebo; Calcium 400 mg + vitamin D 2.5 mcg 2 tablets single dose	Dietary supplement: Calcium 400 mg + Vitamin D 2.5 mcg; 2 chewable tablets provide recommended daily allowance for calcium and vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Weight of subject in Kgs	8 weeks
MUAC	Mid Upper Arm Circumference in cms	8 weeks
TSF	Tricep Skin Fold thickness in mms	8 weeks

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences
• Investigators: Study Director: Dr. Kashif Shafique, PhD, Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2017
• Primary Completion (Actual): June 6, 2017
• Study Completion (Actual): June 6, 2017

Study Registration Dates

• First Submitted: May 14, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): July 13, 2017
• Last Update Submitted That Met QC Criteria: July 11, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: STH; deworming
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Antiprotozoal Agents; Antiparasitic Agents; Anthelmintics; Antiplatyhelmintic Agents; Anticestodal Agents; Vitamin D; Calcium; Albendazole
• Other Study ID Numbers: IRB-816/DUHS/Approval/2016/351

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: If chosen for inclusion in meta analysis, Individual Participant Data (IPD) on outcome variables may be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No