Condition category
Skin and Connective Tissue Diseases
Date applied
31/10/2005
Date assigned
15/11/2005
Last edited
16/10/2008
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

Dr Carsten Flohr

ORCID ID

Contact details

Oxford University Clinical Research Unit
Hospital for Tropical Diseases
Ho Chi Minh City
Viet Nam
flohr@dng.vnn.vn

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

DB Study

Study hypothesis

Allergic disease is becoming increasingly frequent in urban centres of developing nations, such as Viet Nam. In this context, the role of endoparasite exposure has been debated for years. Some but not all cross-sectional studies suggest that the relatively high prevalence of allergic disease and atopy in urban areas of developing countries may be partly explained by a reduction in exposure to endoparasites, especially hookworm and Ascaris lumbricoides. It is likely that some of the effects demonstrated in cross-sectional population-based studies are due to confounding or even reverse causality, such that atopics have an immune system that reduces worm burden. Only an intervention study will be able to clarify this matter.

Ethics approval

Nottingham Research Ethics Committee 2, Ref. REC/Q2010305, 3rd Dec 2004

Study design

Double blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Allergic disease, soil-transmitted helminths

Intervention

The original study protocol used three-monthly single dose Mebendazole 500 mg over one year. After the first treatment round, investigators noticed low efficacy of this regime. Therefore, a treatment comparison study was conducted to select the best treatment, and Albendazole 400 mg for three consecutive days was chosen.

The amended protocol compares three-monthly Albendazole versus placebo over 9 months.

Intervention type

Drug

Phase

Not Specified

Drug names

Albendazole

Primary outcome measures

Change in percent fall in peak expiratory flow after exercise challenge post gut worm treatment

Secondary outcome measures

Change in skin prick test hypersensitivity, host cytokine profiles, and allergic disease prevalence (skin examination for eczema and questionnaire-based for wheeze and rhinitis) post gut worm treatment

Overall trial start date

01/04/2005

Overall trial end date

30/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

All primary and secondary school children (age 6-15) in four communes in Khanh Hoa province, central Viet Nam

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

1600

Participant exclusion criteria

Known allergy to Albendazole

Recruitment start date

01/04/2005

Recruitment end date

30/06/2006

Locations

Countries of recruitment

Viet Nam

Trial participating centre

Oxford University Clinical Research Unit
Ho Chi Minh City
Viet Nam

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

Centre for Population Sciences and Centre for Respiratory Research
Institute of Clinical Research
University of Nottingham
Nottingham
NG7 2RD
United Kingdom
j.britton@virgin.net

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/icr/

Funders

Funder type

Charity

Funder name

Asthma UK (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes