Low Weight for Age in Preschool ChildrenNCT00344669
Effect of Mass Deworming on Child Growth
A study testing Albendazole 400 mg, given 6 monthly in people with Low Weight for Age in Preschool Children, run by Makerere University at 1 site in Uganda.
Trial summary
The purpose of the study was to determine whether periodical mass deworming improves growth in children below six years of age. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Low Weight for Age in Preschool Children
- What is being tested?
- Albendazole 400 mg, given 6 monthly
- How many people
- 10,000 participants
- Where
- 1 siteUganda
- Study dates
- Aug 2000to Nov 2003
- Phase
- Interventional
- 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children 1-6 years
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increased Weight Gain in Preschool Children Due to Mass Albendazole Treatment Given During "Child Health Days" in Uganda
The purpose of the study was to determine whether periodical mass deworming improves growth in children below six years of age.
Read the detailed description
Many children in developing countries get slowed growth because of heavy loads of intestinal helminths. Quite often treatment is not sought because there may not be any obvious symptoms. Slowed growth may manifest as low weight for age or low height for age.
The objective of the study was to estimate the effectiveness of the delivery of an anthelmintic drug through a community child health program on the weight gain of preschool aged children.
Design: This was a cluster randomized controlled trial in 48 parishes in Eastern Uganda. All 48 parishes were participating in a new program for child health; 24 were randomly assigned to offer to children an additional service of anthelmintic treatment. The intervention was 400 mg of albendazole added to the standard services at child days over a 3 years period. All children were offered the drug and the main outcome measure was weight gain.
Results: A total of 27,995 children were recruited into the 2 arms of the study with 14,940 in the treatment arm and 13,055 in the control arm. The intervention arm got an increase in weight gain of about 10% (166 grams per child per year (CI: 16-316) above expected weight gain when treatment was taken twice a year and an increase of 5% when treatment was received approximately annually.
Conclusion: The inclusion of deworming in regularly scheduled health services appears practical and capable of increasing child growth.
- Conditions
- Low Weight for Age in Preschool Children
- Being tested
- Albendazole 400 mg, given 6 monthly
- Keywords
- underweight, preschool, mass deworming
- Medical subject headings
- Thinness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albendazole 400 mg, given 6 monthlyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
weight gain
weight for age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2006 (estimated)
- Study startAug 2000
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Weight for Age in Preschool ChildrenStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 10,000 participants
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Uganda, World Bank
- Investigators
- Joseph K Konde-Lule, MD DPH MSc, Principal investigator, Makerere UniversityJohn F Mutumba, MBChB, MSc, Study chair, Ministry of Health, Uganda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344669
- Sponsor's protocol ID
- P05267
- Status last verified
- Jun 2006
- First submitted
- 14 Jun 2006
- Last updated
- 17 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Weight Gain in Preschool Children Due to Mass Albendazole Treatment Given During "Child Health Days" in Uganda
- ClinicalTrials.gov ID
- NCT00344669
- Acronym / sponsor ID
- P05267
- Conditions
- Low Weight for Age in Preschool Children
- Keywords
- underweight, preschool, mass deworming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,000 participants
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, Uganda, World Bank
- Study start
- Aug 2000
- Study completion
- Nov 2003
- First posted
- 27 Jun 2006 (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.
The purpose of the study was to determine whether periodical mass deworming improves growth in children below six years of age.
Detailed description
Many children in developing countries get slowed growth because of heavy loads of intestinal helminths. Quite often treatment is not sought because there may not be any obvious symptoms. Slowed growth may manifest as low weight for age or low height for age.
The objective of the study was to estimate the effectiveness of the delivery of an anthelmintic drug through a community child health program on the weight gain of preschool aged children.
Design: This was a cluster randomized controlled trial in 48 parishes in Eastern Uganda. All 48 parishes were participating in a new program for child health; 24 were randomly assigned to offer to children an additional service of anthelmintic treatment. The intervention was 400 mg of albendazole added to the standard services at child days over a 3 years period. All children were offered the drug and the main outcome measure was weight gain.
Results: A total of 27,995 children were recruited into the 2 arms of the study with 14,940 in the treatment arm and 13,055 in the control arm. The intervention arm got an increase in weight gain of about 10% (166 grams per child per year (CI: 16-316) above expected weight gain when treatment was taken twice a year and an increase of 5% when treatment was received approximately annually.
Conclusion: The inclusion of deworming in regularly scheduled health services appears practical and capable of increasing child growth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children 1-6 years
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Albendazole 400 mg, given 6 monthly | Drug | – |
Primary outcome
weight gain
weight for 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 17 Oct 2006.
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.
Joseph K Konde-Lule, MD DPH MSc principal investigator
Makerere University
John F Mutumba, MBChB, MSc study chair
Ministry of Health, Uganda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albendazole 400 mg, given 6 monthly in people with Low Weight for Age in Preschool Children, run by Makerere University at 1 site in Uganda.
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 1 inclusion and 1 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 17 Oct 2006. 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 Uganda. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
weight gain. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2006.