AnaemiaNCT00414479
Assessment of Anaemia Attributable to Schistosomiasis in School Children in Kenya: Mechanisms and Effect of Treatment
An observational study of Anaemia and Schistosomiasis Infection, run by DBL -Institute for Health Research and Development at 1 site in Kenya.
Trial summary
The purpose of this study is to determine the extend and the nature of anemia in school children and the correlation between anemia and schistosomiasis infections, malaria infections and/or malnutrition (iron deficiency). Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Anaemia, Schistosomiasis Infection, Malaria
- What is being tested?
- praziquantl, iron, ACT
- How many people
- 1,500 participants
- Where
- 1 siteKenya
- Study dates
- Jul 2006to Jan 2010
- Phase
- Observational
- 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 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: children 9-12 years of age
Who may be able to join
- school children between 9 to 12 year
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the extend and the nature of anemia in school children and the correlation between anemia and schistosomiasis infections, malaria infections and/or malnutrition (iron deficiency).
Read the detailed description
The study will be carried out in an area around Lake Victoria in Kenya where the prevalence of schistosomiasis and malaria are highest in the areas nearest to the Lake. Depending on the prevalence of schistosomiasis a sample of between 876 to 2.524 children will be enrolled in the study. The children who will be in the age between 9 to 12 year, will have their stool and urine examined for schistosomiasis and intestinal worms and a blood sample will be examined for malaria parasites and the hemoglobin level. Children will also be weight, measured and examined by a doctor and register their food intake over one week, to determine their nutritional status. Children who are found to be infected with schistosomiasis, intestinal worms or malaria will be offered treatment. Children who are found to have anemia will be offered a course of iron supplementation, children with severe anemia will be referred to the nearest health facility for treatment. 12 months after the initial examinations and treatment all children will have a re-examination of their stool, urine and blood.
- Conditions
- Anaemia, Schistosomiasis Infection, Malaria, Iron Deficiency
- Being tested
- praziquantl, iron, ACT
- Keywords
- schistosomiasis, anaemia, malaria, iron deficiency
- Medical subject headings
- Anemia, Malaria, Iron Deficiencies, Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
praziquantl, iron, ACTDrug
| Study group | Role | What they receive |
|---|---|---|
| children 9-12 years of age | Children with schistosomiasis, malaria and anaemia Receives: Drug: praziquantl, iron, ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin level
Secondary outcomes (3)
Schistosomiasis infection
malaria infection
iron deficiency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2006 (estimated)
- Study startJul 2006
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- DBL -Institute for Health Research and Development
- Sponsor type
- University, hospital or other
- Investigators
- Diana Karanja, DR, Principal investigator, Kenya Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414479
- Sponsor's protocol ID
- SRP-KY-DK-06
- Status last verified
- Jan 2010
- First submitted
- 20 Dec 2006
- Last updated
- 14 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Anaemia Attributable to Schistosomiasis in School Children in Kenya: Mechanisms and Effect of Treatment
- ClinicalTrials.gov ID
- NCT00414479
- Acronym / sponsor ID
- SRP-KY-DK-06
- Conditions
- Anaemia, Schistosomiasis Infection, Malaria, Iron Deficiency
- Keywords
- schistosomiasis, anaemia, malaria, iron deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- DBL -Institute for Health Research and DevelopmentUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 21 Dec 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 this study is to determine the extend and the nature of anemia in school children and the correlation between anemia and schistosomiasis infections, malaria infections and/or malnutrition (iron deficiency).
Detailed description
The study will be carried out in an area around Lake Victoria in Kenya where the prevalence of schistosomiasis and malaria are highest in the areas nearest to the Lake. Depending on the prevalence of schistosomiasis a sample of between 876 to 2.524 children will be enrolled in the study. The children who will be in the age between 9 to 12 year, will have their stool and urine examined for schistosomiasis and intestinal worms and a blood sample will be examined for malaria parasites and the hemoglobin level. Children will also be weight, measured and examined by a doctor and register their food intake over one week, to determine their nutritional status. Children who are found to be infected with schistosomiasis, intestinal worms or malaria will be offered treatment. Children who are found to have anemia will be offered a course of iron supplementation, children with severe anemia will be referred to the nearest health facility for treatment. 12 months after the initial examinations and treatment all children will have a re-examination of their stool, urine and blood.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children 9-12 years of age | – | Drug: praziquantl, iron, ACTChildren with schistosomiasis, malaria and anaemia |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children 9-12 years of age
Key inclusion criteria (1 listed)
- school children between 9 to 12 year
Key exclusion criteria (0 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 |
|---|---|---|
| praziquantl, iron, ACT | Drug | children 9-12 years of age |
Primary outcome
hemoglobin level
3 secondary outcomes
Schistosomiasis infection
malaria infection
iron deficiency
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 14 Jan 2010.
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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.
Diana Karanja, DR principal investigator
Kenya Medical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaemia and Schistosomiasis Infection, run by DBL -Institute for Health Research and Development at 1 site in Kenya.
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 0 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 14 Jan 2010. 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 Kenya. 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?
hemoglobin level. 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 14 Jan 2010.