NCT00276224

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

October 31, 2007

Status Verified

October 1, 2007

First QC Date

January 12, 2006

Last Update Submit

October 30, 2007

Conditions

Keywords

iron deficiency schistosomiasis soil transmitted helminths

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (8)

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

  • - headache

  • nausea

  • vomiting

  • body weakness

  • +3 more secondary outcomes

Interventions

Eligibility Criteria

Age9 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kenani and Chandwe School

Kenani, Nchelenge district, Zambia

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SchistosomiasisHelminthiasisAnemia

Interventions

ferrous sulfatePharmaceutical Preparations

Condition Hierarchy (Ancestors)

Trematode InfectionsParasitic DiseasesInfectionsVector Borne DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Victor Mwanakasale, Ph.d.,M.Sc.

    Tropical Disease Research Centre, Ndola, Zambia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 13, 2006

Study Start

September 1, 2005

Study Completion

April 1, 2006

Last Updated

October 31, 2007

Record last verified: 2007-10

Locations