Official Title: “Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia”

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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: ferrous sulphate (drug)

Primary 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 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

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

Exclusion Criteria:

-

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 9 Years

Maximum Age for this Clinical Trial: 15 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: DBL -Institute for Health Research and Development

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00276224

Study ID Number: SRP-ZM-VM-04

ClinicalTrials.gov Identifier: NCT00276224

Health Authority: Zambia: Ministry of Health