The Effect of a Deworming Intervention to Improve Early Childhood Growth and Development in Resource-poor Areas
Improving Early Childhood Growth and Development in Resource-poor LMICs by Incorporating Deworming in Integrated Child Health Care
1 other identifier
interventional
1,760
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2011
CompletedFirst Posted
Study publicly available on registry
March 15, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedAugust 26, 2014
August 1, 2014
1.8 years
March 11, 2011
August 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean (± standard deviation) weight gain (kg)
Weight will be measured at baseline (12 months of age), and follow-up (18 and 24 months of age) to assess the effect of the deworming intervention on growth (in terms of weight)
from 12 to 24 months of age
Secondary Outcomes (5)
Mean (± standard deviation) height gain (cm)
from 12 to 24 months of age
Mean (± standard deviation) of the cognitive test score
from 12 to 24 months of age
Soil-transmitted helminth infection (Ascaris, Trichuris or hookworm) - prevalence (%) and intensity (mean eggs per gram)
from 12 to 24 months of age
Mean (± standard deviation) of the motor test score
from 12 to 24 months of age
Mean (± standard deviation) of the language test score
from 12 to 24 months of age
Study Arms (4)
Deworming at 12 months of age
EXPERIMENTALDeworming at 18 months of age
EXPERIMENTALDeworming at 12 and 18 months of age
EXPERIMENTALUsual care
PLACEBO COMPARATORInterventions
Single-dose 500 mg mebendazole tablet
Routine child health interventions (e.g. age-specific immunizations, supplementations, etc.)
Eligibility Criteria
You may qualify if:
- children attending any one of the participating study health centres for their routine 12-month growth and development visit
- children living in or near the study area
You may not qualify if:
- children who are attending the clinic for suspected STH infection
- children who have received deworming treatment in the six months prior to randomization
- parents planning to move outside of the study area within the next 12 months
- children under 12 months of age or 14 months of age or older
- children with serious congenital or chronic medical conditions and who would be considered by the attending staff not to benefit from deworming
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centrelead
- McGill Universitycollaborator
- Asociacion Civil Selva Amazonicacollaborator
- World Health Organizationcollaborator
- Thrasher Research Fundcollaborator
- Canadian Institutes of Health Research (CIHR)collaborator
Study Sites (1)
Asociacion Civil Selva Amazonica
Iquitos, Loreto, Peru
Related Publications (1)
Joseph SA, Casapia M, Montresor A, Rahme E, Ward BJ, Marquis GS, Pezo L, Blouin B, Maheu-Giroux M, Gyorkos TW. The Effect of Deworming on Growth in One-Year-Old Children Living in a Soil-Transmitted Helminth-Endemic Area of Peru: A Randomized Controlled Trial. PLoS Negl Trop Dis. 2015 Oct 1;9(10):e0004020. doi: 10.1371/journal.pntd.0004020. eCollection 2015.
PMID: 26426270DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Theresa W Gyorkos, PhD
McGill University
- PRINCIPAL INVESTIGATOR
Martin Casapia, MD, MPH
Asociacion Civil Selva Amazonica
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 11, 2011
First Posted
March 15, 2011
Study Start
September 1, 2011
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
August 26, 2014
Record last verified: 2014-08