MalnutritionPhase 4NCT01314937
The Effect of a Deworming Intervention to Improve Early Childhood Growth and Development in Resource-poor Areas
A Phase 4 study testing Mebendazole in people with Malnutrition and Intestinal Diseases, Parasitic, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Peru.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Intestinal Diseases, Parasitic
- What is being tested?
- Mebendazole
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,760 participants
- Where
- 1 sitePeru
- Study dates
- Sep 2011to Jul 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Early Childhood Growth and Development in Resource-poor LMICs by Incorporating Deworming in Integrated Child Health Care
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.
Read the 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.
- Conditions
- Malnutrition, Intestinal Diseases, Parasitic
- Being tested
- Mebendazole, Usual care
- Keywords
- preschool-age children, soil-transmitted helminths, growth, development, deworming
- Medical subject headings
- Malnutrition, Intestinal Diseases, Parasitic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MebendazoleDrug
Also called Vermox, Nemasole, Pantelmin
Single-dose 500 mg mebendazole tablet
Usual careOther
Also called Standard of care, routine health care services
Routine child health interventions (e.g. age-specific immunizations, supplementations, etc.)
| Study group | Role | What they receive |
|---|---|---|
| Deworming at 12 months of age | Experimental | Not described Receives: Drug: Mebendazole; Other: Usual care |
| Deworming at 18 months of age | Experimental | Not described Receives: Drug: Mebendazole; Other: Usual care |
| Deworming at 12 and 18 months of age | Experimental | Not described Receives: Drug: Mebendazole; Other: Usual care |
| Usual care | Placebo comparator | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: from 12 to 24 months of age
Secondary outcomes (5)
Mean (± standard deviation) height gain (cm)
Height will be measured at baseline (12 months of age) and at follow-up (18 and 24 months of age) to evaluate the effect of the deworming intervention on growth (in terms of height)
Measured: from 12 to 24 months of age
Mean (± standard deviation) of the cognitive test score
Cognitive development will be assessed using the Bayley Scale of Infant Development. This scale provides a raw score and standardized score based on age-specific abilities. This will be measured at both baseline (12 months of age) and follow-up (at 24 months of age) to evaluate the effects of the deworming intervention on cognitive development.
Measured: from 12 to 24 months of age
Soil-transmitted helminth infection (Ascaris, Trichuris or hookworm) - prevalence (%) and intensity (mean eggs per gram)
Soil-transmitted helminth (STH) infection will be assessed from stool samples provided by participants. The Kato-Katz technique will be used to provide both an estimate of prevalence of each STH (e.g. % positive for each Ascaris, Trichuris, and/or hookworm) as well as an estimate of intensity of each STH (measured as mean eggs per gram of stool). This will be measured at baseline (12 months of age) and follow-up (18 and 24 months of age) to evaluate the effect of the deworming intervention on parasite prevalence and intensity.
Measured: from 12 to 24 months of age
Mean (± standard deviation) of the motor test score
Fine motor development will be assessed using the Bayley Scale of Infant Development. This scale provides a raw score and standardized score based on age-specific abilities. This will be measured at both baseline (12 months of age) and follow-up (at 24 months of age) to evaluate the effects of the deworming intervention on motor development.
Measured: from 12 to 24 months of age
Mean (± standard deviation) of the language test score
Receptive and expressive language development will be assessed using the Bayley Scale of Infant Development. This scale provides a raw score and standardized score based on age-specific abilities. This will be measured at both baseline (12 months of age) and follow-up (at 24 months of age) to evaluate the effects of the deworming intervention on language development.
Measured: from 12 to 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University, Asociacion Civil Selva Amazonica, World Health Organization, Thrasher Research Fund, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Dr. Theresa Gyorkos, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Theresa W Gyorkos, PhD, Principal investigator, McGill UniversityMartin Casapia, MD, MPH, Principal investigator, Asociacion Civil Selva Amazonica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314937
- Sponsor's protocol ID
- 10-242-PED
- Status last verified
- Aug 2014
- First submitted
- 11 Mar 2011
- Last updated
- 26 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26426270
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Early Childhood Growth and Development in Resource-poor LMICs by Incorporating Deworming in Integrated Child Health Care
- ClinicalTrials.gov ID
- NCT01314937
- Acronym / sponsor ID
- 10-242-PED
- Conditions
- Malnutrition, Intestinal Diseases, Parasitic
- Keywords
- preschool-age children, soil-transmitted helminths, growth, development, deworming
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,760 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- McGill University, Asociacion Civil Selva Amazonica, World Health Organization, Thrasher Research Fund, Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Deworming at 12 months of age | Experimental | Drug: Mebendazole, Other: Usual care |
| Deworming at 18 months of age | Experimental | Drug: Mebendazole, Other: Usual care |
| Deworming at 12 and 18 months of age | Experimental | Drug: Mebendazole, Other: Usual care |
| Usual care | Placebo comparator | Other: Usual care |
Who may qualify
- Ages
- 12 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MebendazoleAlso: Vermox, Nemasole, PantelminSingle-dose 500 mg mebendazole tablet | Drug | Deworming at 12 and 18 months of age, Deworming at 12 months of age, Deworming at 18 months of age |
| Usual careAlso: Standard of care, routine health care servicesRoutine child health interventions (e.g. age-specific immunizations, supplementations, etc.) | Other | Deworming at 12 and 18 months of age, Deworming at 12 months of age, Deworming at 18 months of age, Usual care |
Primary outcome
Mean (± standard deviation) weight gain (kg)
Time frame: from 12 to 24 months of age
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)
5 secondary outcomes
Mean (± standard deviation) height gain (cm)
Time frame: from 12 to 24 months of age
Mean (± standard deviation) of the cognitive test score
Time frame: from 12 to 24 months of age
Soil-transmitted helminth infection (Ascaris, Trichuris or hookworm) - prevalence (%) and intensity (mean eggs per gram)
Time frame: from 12 to 24 months of age
Mean (± standard deviation) of the motor test score
Time frame: from 12 to 24 months of age
Mean (± standard deviation) of the language test score
Time frame: from 12 to 24 months of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2014.
- Derived from this study: PubMed 26426270Joseph 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa W Gyorkos, PhD principal investigator
McGill University
Martin Casapia, MD, MPH principal investigator
Asociacion Civil Selva Amazonica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mebendazole in people with Malnutrition and Intestinal Diseases, Parasitic, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean (± standard deviation) weight gain (kg) (time frame: from 12 to 24 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01314937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2014.