Effects of intestinal helminth infections in early childhood on immune response, inflammation, anaemia and malnutrition

ISRCTN	ISRCTN83988447
DOI	https://doi.org/10.1186/ISRCTN83988447
Protocol serial number	063122
Sponsor	Cornell University (USA)
Funders	The Wellcome Trust (UK) (grant ref: 063122), Burroughs Wellcome Initiative (USA)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Ms Rebecca J Stoltzfus
Scientific

Cornell University
Division of Nutritional Sciences
120 Savage Hall
Ithaca NY
14853
United States of America

Phone	+1 607 255 7671
Email	rjs62@cornell.edu

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To test whether anthelminthic treatment of children six to 36 months of age decreases severe anaemia, decreases wasting malnutrition, and decreases anorexia.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Mebendazole
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
Key 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
Completion date	31/03/2006

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	24 Months
Sex	All
Target sample size at registration	2500
Key inclusion criteria	1. Six to 24 months of age 2. Informed consent 3. Residing in selected communities based on geographic catchment area
Key exclusion criteria	1. Haemoglobin less than 70 g/l 2. Refusal of informed consent
Date of first enrolment	01/01/2004
Date of final enrolment	31/03/2006

Cornell University

Ithaca NY
14853
United States of America

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan