Effect of Routine Deworming on Weight of Children

NCT03155035 | Completed

• 1 other identifier: IRB-816/DUHS/Approval/2016/351
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Soil Transmitted Helminths

Keywords

deworming; STH

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

Albendazole 200 mg 2 tablets single dose

Drug: Albendazole

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Calcium 400 mg + Vitamin D 2.5 mcg

Interventions

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

Intervention

Calcium 400 mg + Vitamin D 2.5 mcg DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, 74200, Pakistan

Location

MeSH Terms

Interventions

Albendazole; Calcium; Vitamin D

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Dr. Kashif Shafique, PhD

  Dow University of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 14, 2017
• First Posted: May 16, 2017
• Study Start: March 7, 2017
• Primary Completion: June 6, 2017
• Study Completion: June 6, 2017
• Last Updated: July 13, 2017

Record last verified: 2017-07

Locations

PA (1)