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Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00276224
First Posted: January 13, 2006
Last Update Posted: October 31, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
DBL -Institute for Health Research and Development
  Purpose

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

Condition Intervention
Schistosomiasis Helminthiases Anaemia Drug: ferrous sulphate (drug)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia

Resource links provided by NLM:


Further study details as provided by DBL -Institute for Health Research and Development:

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

Estimated Enrollment: 480
Study Start Date: September 2005
Estimated Study Completion Date: April 2006
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:all schoolchildren, in grade 2 and 3, at four selected schools -

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276224


Locations
Zambia
Kenani and Chandwe School
Kenani, Nchelenge district, Zambia
Sponsors and Collaborators
DBL -Institute for Health Research and Development
Investigators
Principal Investigator: Victor Mwanakasale, Ph.d.,M.Sc. Tropical Disease Research Centre, Ndola, Zambia
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00276224     History of Changes
Other Study ID Numbers: SRP-ZM-VM-04
First Submitted: January 12, 2006
First Posted: January 13, 2006
Last Update Posted: October 31, 2007
Last Verified: October 2007

Keywords provided by DBL -Institute for Health Research and Development:
iron deficiency schistosomiasis soil transmitted helminths

Additional relevant MeSH terms:
Schistosomiasis
Helminthiasis
Trematode Infections
Parasitic Diseases