Clinical trial NCT00276224: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schistosomiasis
Helminthiases
Anaemia
Keywords: iron deficiency schistosomiasis soil transmitted helminths
Lead sponsor: DBL -Institute for Health Research and Development
Sponsor class: OTHER
First posted: 2006-01-13
Enrollment: 480
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Exclusion Criteria:

-

Primary outcomes:
measure: Urine samples examined for schistsoma haematobium at month 0, 3. 6 and 9
measure: Stool samples examined for schistsoma mansoni at mont 0, 3, 6 and 9
measure: Blood samples examined for haemoglobin level mont 0 and month 9
Secondary outcomes:
measure: Any side effects to iron supplementation, measured every week for the first foru weeks after treatment start. Mesured on:
measure: - headache
measure: nausea
measure: vomiting
measure: body weakness
measure: diarrhoea
measure: abdominal pain
measure: others
Other outcomes:
Locations:
city: Kenani
country: Zambia
facility: Kenani and Chandwe School
state: Nchelenge district
Study officials:
affiliation: Tropical Disease Research Centre, Ndola, Zambia
name: Victor Mwanakasale, Ph.d.,M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mwanakasale V, Siziya S, Mwansa J, Koukounari A, Fenwick A. Impact of iron supplementation on schistosomiasis control in Zambian school children in a highly endemic area. Malawi Med J. 2009 Mar;21(1):12-8. doi: 10.4314/mmj.v21i1.10982.