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

This study has been completed.
Sponsor:
Information provided by:
DBL -Institute for Health Research and Development
ClinicalTrials.gov Identifier:
NCT00276224
First received: January 12, 2006
Last updated: October 30, 2007
Last verified: October 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   9 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

Exclusion Criteria:

-

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by DBL -Institute for Health Research and Development

Additional 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
Study First Received: January 12, 2006
Last Updated: October 30, 2007
Health Authority: Zambia: Ministry of Health

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

ClinicalTrials.gov processed this record on October 01, 2014