The Effect of a Deworming Intervention to Improve Early Childhood Growth and Development in Resource-poor Areas
Information source: McGill University Health Center
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malnutrition; Intestinal Diseases, Parasitic
Intervention: Mebendazole (Drug); Usual care (Other)
Phase: Phase 4
Status: Recruiting
Sponsored by: McGill University Health Center Official(s) and/or principal investigator(s):
Theresa W Gyorkos, PhD, Principal Investigator, Affiliation: McGill University
Martin Casapia, MD, MPH, Principal Investigator, Affiliation: Asociacion Civil Selva Amazonica
Overall contact:
Serene A Joseph, MSc, Phone: 514-934-1934, Ext: 44841, Email: serene.joseph@mail.mcgill.ca
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.
Clinical Details
Official title: Improving Early Childhood Growth and Development in Resource-poor LMICs by Incorporating Deworming in Integrated Child Health Care
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Mean (± standard deviation) weight gain (kg)
Secondary outcome: Mean (± standard deviation) height gain (cm)Mean (± standard deviation) of the cognitive test score Soil-transmitted helminth infection (Ascaris, Trichuris or hookworm) - prevalence (%) and intensity (mean eggs per gram) Mean (± standard deviation) of the motor test score Mean (± standard deviation) of the language test score
Detailed description:
Worldwide, over 2 billion people suffer from worm infections (hookworm, Ascaris and
Trichuris, collectively referred to as soil-transmitted helminths (STHs)) in developing
countries. STHs contribute to the overwhelming burden of poverty and deprivation in areas
where adverse health, social, economic, education and other related factors predominate. STH
infection in childhood results in short-term and lifelong disability, including malnutrition
(e. g. underweight, stunting and wasting), cognitive impairment and increased susceptibility
to other infection, among others. Mass deworming programs in school-age children are
recommended by the World Health Organization (WHO). WHO also recommends deworming of
preschool children (as of 12 months of age) in endemic areas; however, the benefits of
deworming on improving growth and development, especially in the 12-24 month age group, have
been inadequately studied. This knowledge is crucial because, with appropriate nutrition and
health interventions, all children have a similar potential for healthy growth and
development, provided that such interventions occur in the critical window of opportunity
before the age of two.
Therefore, this double-blind randomized controlled trial will assess the benefit of
deworming (mebendazole), integrated into routine child health care visits in a highly
STH-endemic area (Iquitos, Peru), on the primary outcome of weight gain. Timing, frequency
and impact of deworming will be considered. A total of 1760 children will be recruited at
their routine 12-month check-up visit and randomly assigned to one of four intervention
groups: Group 1 will receive usual care and mebendazole (single dose 500 mg) at their
12-month visit and usual care and a placebo tablet at their 18-month visit; Group 2 will
receive usual care and a placebo tablet at their 12-month visit and usual care and
mebendazole at their 18-month visit; Group 3 will receive usual care and mebendazole at both
their 12-month and 18-month visit; and Group 4 will receive usual care and placebo at both
their 12-month and 18-month visit. Usual care will consist of age-appropriate immunizations,
supplements and other Peruvian Ministry of Health-recommended interventions. All children
will be followed up to their 24-month visit and all will be given mebendazole at that time.
Additional secondary outcomes include length gain, motor and cognitive development and STH
prevalence and intensity.
Improving child health is a priority area in global health research and a focus of the
Millennium Development Goals. Early preschool-age children are at the most critical stage of
growth and development and have been neglected in deworming programs. It is anticipated that
the results will inform evidence-based policy on the provision of an integrated health
package for young children in endemic areas and ultimately contribute to the reduction of
health inequities in this vulnerable group.
Eligibility
Minimum age: 12 Months.
Maximum age: 24 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Serene A Joseph, MSc, Phone: 514-934-1934, Ext: 44841, Email: serene.joseph@mail.mcgill.ca
Asociacion Civil Selva Amazonica, Iquitos, Loreto, Peru; Recruiting
Serene Joseph, MSc, Phone: +51965639178
Theresa W Gyorkos, PhD, Principal Investigator
Martin Casapia, MD, MPH, Principal Investigator
Additional Information
Starting date: September 2011
Last updated: September 21, 2011
|
