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
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
- collaborator OTHER
-
Asociacion Civil Selva Amazonica
collaborator OTHER - 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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