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

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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

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.

Study Type

Interventional

Primary Outcome

Urine samples examined for schistsoma haematobium at month 0, 3. 6 and 9

Secondary Outcome

 Any side effects to iron supplementation, measured every week for the first foru weeks after treatment start. Mesured on:

Condition

Schistosomiasis

Intervention

ferrous sulphate (drug)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

480

Start Date

September 2005

Completion Date

April 2006

Eligibility Criteria

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

        Exclusion Criteria:

        -

Gender

All

Ages

9 Years - 15 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Victor Mwanakasale, Ph.d.,M.Sc., ,

Location Countries

Zambia

Location Countries

Zambia

Administrative Informations

NCT ID

NCT00276224

Organization ID

SRP-ZM-VM-04

Study Sponsor

DBL -Institute for Health Research and Development

Study Sponsor

Victor Mwanakasale, Ph.d.,M.Sc., Principal Investigator, Tropical Disease Research Centre, Ndola, Zambia

Verification Date

October 2007