Condition category
Infections and Infestations
Date applied
28/07/2008
Date assigned
25/09/2008
Last edited
16/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Celia Holland

ORCID ID

Contact details

Department of Zoology
The University of Dublin
Trinity College
Dublin
02
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Deworming does not increase the incidence of malaria or the frequency of malaria attacks in pre-school children.

Ethics approval

The Ethics and Research Committee of Obafemi Awolowo University Teaching Hospitals' Complex (Nigeria) gave approval on the 13th April 2006 (ref: ERC/2006/03/16)

Study design

Double-blind placebo-controlled randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Malaria, helminth parasitisation

Intervention

There were two groups: the treatment (albendazole) group and the placebo group. A dose of 200 mg (one tablet) of albendazole was given to children aged 1 year. A dose of 400 mg (two tablets) of albendazole was given to children aged 2, 3 and 4 years. Children who were in the placebo group and aged 1 year were given one placebo tablet and children aged 2, 3 and 4 years were given two placebo tablets.

Children were given treatment or placebo at baseline, 4, 8 and 12 months and then followed up for the last time at 14 months. Children in the placebo group were treated with albendazole at 14 months.

Intervention type

Drug

Phase

Not Applicable

Drug names

Albendazole

Primary outcome measures

1. Incidence of malaria, measured at baseline and 4, 8, 12 and 14 months
2. Malaria attacks, measured at baseline and 4, 8, 12 and 14 months
3. Infection with soil-transmitted helminths, measured at baseline and 4, 8, 12 and 14 months

Secondary outcome measures

1. Nutritional status, measured at baseline and 14 months
2. Haemoglobin, measured at baseline and 4, 8, 12 and 14 months

Overall trial start date

16/05/2006

Overall trial end date

22/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Pre-school children aged 12 - 59 months, either sex

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

1055

Participant exclusion criteria

1. Severe anaemia less than 5 g/dl
2. Severe malaria

Recruitment start date

16/05/2006

Recruitment end date

22/08/2007

Locations

Countries of recruitment

Nigeria

Trial participating centre

Department of Zoology
Dublin
02
Ireland

Sponsor information

Organisation

The University of Dublin (Ireland)

Sponsor details

Trinity College
Dublin
02
Ireland

Sponsor type

University/education

Website

http://www.tcd.ie/

Funders

Funder type

Government

Funder name

Health Research Board (HRB) (Ireland)

Alternative name(s)

HRB

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Ireland

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 anthelmintic results in http://www.ncbi.nlm.nih.gov/pubmed/19228385

Publication citations

  1. Anthelmintic results

    Kirwan P, Asaolu SO, Molloy SF, Abiona TC, Jackson AL, Holland CV, Patterns of soil-transmitted helminth infection and impact of four-monthly albendazole treatments in preschool children from semi-urban communities in Nigeria: a double-blind placebo-controlled randomised trial., BMC Infect. Dis., 2009, 9, 20, doi: 10.1186/1471-2334-9-20.

Additional files

Editorial Notes