|
ISRCTN
|
ISRCTN83988447
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Effects of intestinal helminth infections in early childhood on immune response, inflammation, anaemia and malnutrition
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
063122
|
|
Study hypothesis
|
To test whether anthelminthic treatment of children six to 36 months of age decreases severe anaemia, decreases wasting malnutrition, and decreases anorexia.
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
Tanzania
|
|
Disease/condition/study domain
|
Anaemia, protein-energy malnutrition, anorexia
|
|
Participants - inclusion criteria
|
1. Six to 24 months of age
2. Informed consent
3. Residing in selected communities based on geographic catchment area
|
|
Participants - exclusion criteria
|
1. Haemoglobin less than 70 g/l
2. Refusal of informed consent
|
|
Anticipated start date
|
01/01/2004
|
|
Anticipated end date
|
31/03/2006
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
2500
|
|
Interventions
|
Double blind Randomised Controlled Trial (RCT) of mebendazole versus an identical-looking but inert placebo.
|
|
Primary outcome measure(s)
|
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 measure(s)
|
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
|
|
Sources of funding
|
1. The Wellcome Trust (UK) (grant ref: 063122)
2. Burroughs Wellcome Initiative (USA)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Ms
Rebecca J
Stoltzfus
|
|
Address
|
Cornell University
Division of Nutritional Sciences
120 Savage Hall
|
|
City/town
|
Ithaca NY
|
|
Zip/Postcode
|
14853
|
|
Country
|
United States of America
|
|
Tel
|
+1 607 255 7671
|
|
Fax
|
+1 607 255 1033
|
|
Email
|
rjs62@cornell.edu
|
|
Sponsor
|
Cornell University (USA)
|
|
Address
|
Division of Nutritional Sciences
|
|
City/town
|
Ithaca, NY
|
|
Zip/Postcode
|
14853
|
|
Country
|
United States of America
|
|
Tel
|
+1 607 255 2946
|
|
Fax
|
+1 607 255 1033
|
|
Email
|
crf1@cornell.edu
|
|
Sponsor website:
|
http://www.cornell.edu/
|
|
Date applied
|
22/07/2005
|
|
Last edited
|
13/12/2007
|
|
Date ISRCTN assigned
|
22/07/2005
|
