Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia
Primary Purpose
Schistosomiasis, Helminthiases, Anaemia
Status
Completed
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
ferrous sulphate (drug)
Sponsored by
About this trial
This is an interventional treatment trial for Schistosomiasis focused on measuring iron deficiency schistosomiasis soil transmitted helminths
Eligibility Criteria
Inclusion Criteria:all schoolchildren, in grade 2 and 3, at four selected schools - Exclusion Criteria: -
Sites / Locations
- Kenani and Chandwe School
Outcomes
Primary Outcome Measures
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 Outcome Measures
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
Full Information
NCT ID
NCT00276224
First Posted
January 12, 2006
Last Updated
October 30, 2007
Sponsor
DBL -Institute for Health Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT00276224
Brief Title
Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia
Official Title
Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
DBL -Institute for Health Research and Development
4. Oversight
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schistosomiasis, Helminthiases, Anaemia
Keywords
iron deficiency schistosomiasis soil transmitted helminths
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
480 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ferrous sulphate (drug)
Primary Outcome Measure Information:
Title
Urine samples examined for schistsoma haematobium at month 0, 3. 6 and 9
Title
Stool samples examined for schistsoma mansoni at mont 0, 3, 6 and 9
Title
Blood samples examined for haemoglobin level mont 0 and month 9
Secondary Outcome Measure Information:
Title
Any side effects to iron supplementation, measured every week for the first foru weeks after treatment start. Mesured on:
Title
- headache
Title
nausea
Title
vomiting
Title
body weakness
Title
diarrhoea
Title
abdominal pain
Title
others
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:all schoolchildren, in grade 2 and 3, at four selected schools -
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Mwanakasale, Ph.d.,M.Sc.
Organizational Affiliation
Tropical Disease Research Centre, Ndola, Zambia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kenani and Chandwe School
City
Kenani
State/Province
Nchelenge district
Country
Zambia
12. IPD Sharing Statement
Citations:
PubMed Identifier
19780472
Citation
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.
Results Reference
derived
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Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia
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