Condition category
Haematological Disorders
Date applied
22/07/2005
Date assigned
22/07/2005
Last edited
13/12/2007
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

Ms Rebecca J Stoltzfus

ORCID ID

Contact details

Cornell University
Division of Nutritional Sciences
120 Savage Hall
Ithaca NY
14853
United States of America
+1 607 255 7671
rjs62@cornell.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

063122

Study information

Scientific title

Acronym

Study hypothesis

To test whether anthelminthic treatment of children six to 36 months of age decreases severe anaemia, decreases wasting malnutrition, and decreases anorexia.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Anaemia, protein-energy malnutrition, anorexia

Intervention

Double blind Randomised Controlled Trial (RCT) of mebendazole versus an identical-looking but inert placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Mebendazole

Primary outcome measures

1. Haemoglobin less than 70 g/l
2. Mid upper arm circumference less than -2 Z scores of international reference
3. Maternal report of anorexia

Secondary outcome measures

1. Weight-for-height less than -1 Z scores of international reference
2. Height-for-age less than -2 Z scores on international reference
3. Inflammation

Overall trial start date

01/01/2004

Overall trial end date

31/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Six to 24 months of age
2. Informed consent
3. Residing in selected communities based on geographic catchment area

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

2500

Participant exclusion criteria

1. Haemoglobin less than 70 g/l
2. Refusal of informed consent

Recruitment start date

01/01/2004

Recruitment end date

31/03/2006

Locations

Countries of recruitment

Tanzania

Trial participating centre

Cornell University
Ithaca NY
14853
United States of America

Sponsor information

Organisation

Cornell University (USA)

Sponsor details

Division of Nutritional Sciences
Ithaca
NY
14853
United States of America
+1 607 255 2946
crf1@cornell.edu

Sponsor type

University/education

Website

http://www.cornell.edu/

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 063122)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Burroughs Wellcome Initiative (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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