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

Anaemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276224
• Other study ID #: SRP-ZM-VM-04
• Status: Completed
• Phase: N/A
• First received: January 12, 2006
• Last updated: October 30, 2007
• Start date: September 2005
• Est. completion date: April 2006

Study information

• Verified date: October 2007
• Source: DBL -Institute for Health Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: Zambia: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 15 Years

Eligibility

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

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaemia
• Helminthiases
• Helminthiasis
• Schistosomiasis

Intervention

Drug:
• ferrous sulphate (drug)

Locations

Country	Name	City	State
Zambia	Kenani and Chandwe School	Kenani	Nchelenge district

Sponsors (1)

Lead Sponsor	Collaborator
DBL -Institute for Health Research and Development

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine samples examined for schistsoma haematobium at month 0, 3. 6 and 9
Primary	Stool samples examined for schistsoma mansoni at mont 0, 3, 6 and 9
Primary	Blood samples examined for haemoglobin level mont 0 and month 9
Secondary	Any side effects to iron supplementation, measured every week for the first foru weeks after treatment start. Mesured on:
Secondary	- headache
Secondary	nausea
Secondary	vomiting
Secondary	body weakness
Secondary	diarrhoea
Secondary	abdominal pain
Secondary	others