Iron fortification and parasite control to reduce anaemia among schoolchildren in Cote d'Ivoire

ISRCTN	ISRCTN21782274
DOI	https://doi.org/10.1186/ISRCTN21782274
Protocol serial number	PPOOB--102883
Sponsor	ETH Food Science and Nutrition (Switzerland)
Funder	The Medicor Foundation (Liechtenstein)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Michael B. Zimmermann
Scientific

ETH Food Science and Nutrition
Human Nutrition Laboratory, LFV E 19
Schmelzbergstrasse 7
Zurich
8092
Switzerland

Phone	+41 (0)44 632-8657
Email	michael.zimmermann@ilw.agrl.ethz.ch

Primary study design	Interventional
Study design	Randomised, double-blind, clinical trial (2 x 2 x 2 factorial design)
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	IronSPAlbenPrazi
Study objectives	Iron fortification, intermittent preventive treatment for malaria, and regular anti-helmintic treatment - alone and in combination - reduce anaemia in schoolchildren.
Ethics approval(s)	Approval received from the local Ethics Committee (Ethikkommission Beider Basel [EKBB]) on the 4th September 2006, and the 28th September 2006 (Protocol Number: 224/06).
Health condition(s) or problem(s) studied	Mild to moderate anaemia
Intervention	1. Iron fortification (biscuitis with two x 10 mg Fe/day/child; four per week) 2. Intermittent preventative treatment (sulfadoxine (500 mg) and pyrimethamine (25 mg); three times, interval: three-month) 3. Albendazole (400 mg) and praziquantel (40 mg/kg); three times, interval: three-month
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Iron fortification, sulfadoxine, pyrimethamine, albendazole and praziquantel
Primary outcome measure(s)	1. Reduction in anaemia 2. Change in cognitive performance
Key secondary outcome measure(s)	Number of clinical malaria episodes during trial period
Completion date	31/08/2007

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Years
Upper age limit	14 Years
Sex	All
Target sample size at registration	640
Key inclusion criteria	1. Child, aged six to 14 years, both sexes, attending the local primary school of five selected villages 2. For girls, not pregnant (as assessed by medical doctor) 3. Absence of major systemic illnesses (as assessed by medical doctor upon initial full clinical assessment) 4. Anticipated residence in the study area for at least one year 5. Mild to moderate anaemia defined as Haemoglobin (Hb) more than 80 g/L and less than 115 g/L in children aged between six and 12 years, and Hb more than 80 g/Land less than 120 g/L in children more than or equal to 12 years 6. No known or reported hypersensitivity to albendazole, praziquantel or sulfadoxine-pyrimethamine 7. No known or reported history of significant chronic illness 8. No known history of anthelmintic treatment in the four weeks prior to study enrolment 9. Written informed consent of parents or legal guardian
Key exclusion criteria	1. Hb less than 80g/L 2. Attending any other clinical trials during the study period 3. Presence of any abnormal medical condition, judged by the investigator medical team
Date of first enrolment	27/11/2006
Date of final enrolment	31/08/2007

ETH Food Science and Nutrition

Zurich
8092
Switzerland

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

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/01/2008	Yes	No
Results article	results	01/03/2010	Yes	No
Results article	results	01/12/2010	Yes	No