The Effect of a Deworming Intervention to Improve Early Childhood Growth and Development in Resource-poor Areas

NCT01314937 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1760

Last updated 2014-08-26

No results posted yet for this study

Summary

Worldwide, over 2 billion people suffer from worm infections in developing countries. These infections are especially damaging to the health of children, resulting in both short-term and lifelong disability. Older children with worm infections are more likely to be stunted, underweight, vulnerable to other illnesses and perform poorly in school compared to non-infected children. Large-scale deworming programs in school-age children are therefore recommended by the World Health Organization (WHO). WHO also recommends deworming of preschool-age children (as of 12 months of age) in these areas; however, the benefits of deworming, especially in the 12-24 month age group, have been inadequately studied. This knowledge is urgently needed as studies show that all children have a similar potential for healthy growth and development, provided that appropriate nutrition and health interventions are given in the critical window of opportunity before the age of two.

Therefore, the investigators are proposing to undertake a randomized controlled trial to determine the effect of deworming program for improving growth and development in children between 12 and 24 months of age. Our results will provide solid rigorous evidence on if, when, and how often, deworming should be integrated into routine child health care packages provided by Ministries of Health in the 130 countries in the world where worm infections are endemic.

Conditions

  • Malnutrition
  • Intestinal Diseases, Parasitic

Interventions

DRUG

Mebendazole

Single-dose 500 mg mebendazole tablet

OTHER

Usual care

Routine child health interventions (e.g. age-specific immunizations, supplementations, etc.)

Sponsors & Collaborators

  • McGill University

    collaborator OTHER
  • Asociacion Civil Selva Amazonica

    collaborator OTHER
  • World Health Organization

    collaborator OTHER
  • Thrasher Research Fund

    collaborator OTHER
  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    lead OTHER

Principal Investigators

  • Theresa W Gyorkos, PhD · McGill University

  • Martin Casapia, MD, MPH · Asociacion Civil Selva Amazonica

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Peru

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01314937 on ClinicalTrials.gov