SchistosomiasisNCT00276224
Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia
A study testing ferrous sulphate (drug) in people with Schistosomiasis and Helminthiases, run by DBL -Institute for Health Research and Development at 1 site in Zambia.
Trial summary
The objectives of this study is: to establish the coverage rate of weekly iron supplementation in children in intervention schools over a period of nine months document any side effects of weeekly iron supplementation among children in intervention schools over a period of nine months asses the feasibility of… Read more about this study
- Who is it for?
- Ages 9 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Schistosomiasis, Helminthiases, Anaemia
- What is being tested?
- ferrous sulphate (drug)
- How many people
- 480 participants
- Where
- 1 siteZambia
- Study dates
- Sep 2005to Apr 2006
- 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 9 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of this study is:
- to establish the coverage rate of weekly iron supplementation in children in intervention schools over a period of nine months
- document any side effects of weeekly iron supplementation among children in intervention schools over a period of nine months asses the feasibility of incorporating the weekly iron supplementation programme into the normal school activity in intervention schools determine the extent of acceptability and support for the iron supplementation programme by staff at the health centre nearest to the intervention schools
- compare the praziquantel efficacy and schistosomiasis reinfection in children in intervention schools with that of children in control schools following the introduction of weekely iron supplementation over a period of nine months
- determine the impact of weekly iron supplementation on haemoglobin levels of children in intervention schools and compare with children in control schools over a period of nine months
Read the detailed description
Iron deficiency anaemia is a common denominator for both schistosomiasis and soil transmitted helminths. Iron deficiency appears to affect the immune response against schistosomes and intestinal helminths. It therefore follows that correcting the iron deficiency anaemia will improve the efficacy of anthelminthics such as praziquantel (against schistosomiasis) and albendazol (against soil transmitted helminths) and ability of the host immune system to resist reinfection with schistosomes and soil transmitted helminths.
The aim of this study is to identify factors necessary for a successful weekly iron supplementation programme in schistosomiasis and soil transmitted helminths control programmes. In addition impact of weekly iron supplementation programme n haemoglobin levels, efficacy of praziquantel, and schistosomiasis re-infection will be studied.
- Conditions
- Schistosomiasis, Helminthiases, Anaemia
- Being tested
- ferrous sulphate (drug)
- Keywords
- iron deficiency schistosomiasis soil transmitted helminths
- Medical subject headings
- Schistosomiasis, Helminthiasis, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferrous sulphate (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine samples examined for schistsoma haematobium at month 0, 3. 6 and 9
Stool samples examined for schistsoma mansoni at mont 0, 3, 6 and 9
Blood samples examined for haemoglobin level mont 0 and month 9
Secondary outcomes (8)
Any side effects to iron supplementation, measured every week for the first foru weeks after treatment start. Mesured on:
- headache
nausea
vomiting
body weakness
diarrhoea
abdominal pain
others
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startSep 2005
- Study completionApr 2006
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 SchistosomiasisStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 480 participants
Sponsor and investigators
- Lead sponsor
- DBL -Institute for Health Research and Development
- Sponsor type
- University, hospital or other
- Investigators
- Victor Mwanakasale, Ph.d.,M.Sc., Principal investigator, Tropical Disease Research Centre, Ndola, Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276224
- Sponsor's protocol ID
- SRP-ZM-VM-04
- Status last verified
- Oct 2007
- First submitted
- 12 Jan 2006
- Last updated
- 31 Oct 2007
- Results posted
- No
Publications
Mwanakasale V, Siziya S, Mwansa J, Koukounari A, Fenwick A. Impact of iron supplementation on schistosomiasis control in Zambian school children in a highly endemic area. Malawi Med J. 2009 Mar;21(1):12-8. doi: 10.4314/mmj.v21i1.10982.
PubMed 19780472
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia
- ClinicalTrials.gov ID
- NCT00276224
- Acronym / sponsor ID
- SRP-ZM-VM-04
- Conditions
- Schistosomiasis, Helminthiases, Anaemia
- Keywords
- iron deficiency schistosomiasis soil transmitted helminths
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants
- Lead sponsor
- DBL -Institute for Health Research and DevelopmentUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Apr 2006
- First posted
- 13 Jan 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 objectives of this study is:
- to establish the coverage rate of weekly iron supplementation in children in intervention schools over a period of nine months
- document any side effects of weeekly iron supplementation among children in intervention schools over a period of nine months asses the feasibility of incorporating the weekly iron supplementation programme into the normal school activity in intervention schools determine the extent of acceptability and support for the iron supplementation programme by staff at the health centre nearest to the intervention schools
- compare the praziquantel efficacy and schistosomiasis reinfection in children in intervention schools with that of children in control schools following the introduction of weekely iron supplementation over a period of nine months
- determine the impact of weekly iron supplementation on haemoglobin levels of children in intervention schools and compare with children in control schools over a period of nine months
Detailed description
Iron deficiency anaemia is a common denominator for both schistosomiasis and soil transmitted helminths. Iron deficiency appears to affect the immune response against schistosomes and intestinal helminths. It therefore follows that correcting the iron deficiency anaemia will improve the efficacy of anthelminthics such as praziquantel (against schistosomiasis) and albendazol (against soil transmitted helminths) and ability of the host immune system to resist reinfection with schistosomes and soil transmitted helminths.
The aim of this study is to identify factors necessary for a successful weekly iron supplementation programme in schistosomiasis and soil transmitted helminths control programmes. In addition impact of weekly iron supplementation programme n haemoglobin levels, efficacy of praziquantel, and schistosomiasis re-infection will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
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 |
|---|---|---|
| ferrous sulphate (drug) | Drug | – |
Primary outcome
Urine samples examined for schistsoma haematobium at month 0, 3. 6 and 9
Stool samples examined for schistsoma mansoni at mont 0, 3, 6 and 9
Blood samples examined for haemoglobin level mont 0 and month 9
8 secondary outcomes
Any side effects to iron supplementation, measured every week for the first foru weeks after treatment start. Mesured on:
- headache
nausea
vomiting
body weakness
diarrhoea
abdominal pain
others
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 31 Oct 2007.
- Derived from this study: PubMed 19780472Mwanakasale V, Siziya S, Mwansa J, Koukounari A, Fenwick A. Impact of iron supplementation on schistosomiasis control in Zambian school children in a highly endemic area. Malawi Med J. 2009 Mar;21(1):12-8. doi: 10.4314/mmj.v21i1.10982.
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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.
Victor Mwanakasale, Ph.d.,M.Sc. principal investigator
Tropical Disease Research Centre, Ndola, Zambia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ferrous sulphate (drug) in people with Schistosomiasis and Helminthiases, run by DBL -Institute for Health Research and Development at 1 site in Zambia.
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 0 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 31 Oct 2007. 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 Zambia. 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?
Urine samples examined for schistsoma haematobium at month 0, 3. 6 and 9. The study lists 3 primary outcomes in all. 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 NCT00276224, 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 31 Oct 2007.