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Iron fortification and parasite control to reduce anaemia among schoolchildren in Cote d'Ivoire
ISRCTN ISRCTN21782274
DOI 10.1186/ISRCTN21782274
ClinicalTrials.gov identifier
EudraCT number
Public title Iron fortification and parasite control to reduce anaemia among schoolchildren in Cote d'Ivoire
Scientific title
Acronym IronSPAlbenPrazi
Serial number at source PPOOB--102883
Study hypothesis Iron fortification, intermittent preventive treatment for malaria, and regular anti-helmintic treatment - alone and in combination - reduce anaemia in schoolchildren.
Lay summary Not provided at time of registration
Ethics approval 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).
Study design Randomised, double-blind, clinical trial (2 x 2 x 2 factorial design)
Countries of recruitment Cote d'Ivoire
Disease/condition/study domain Mild to moderate anaemia
Participants - 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
Participants - 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
Anticipated start date 27/11/2006
Anticipated end date 31/08/2007
Status of trial Completed
Patient information material
Target number of participants 640
Interventions 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
Primary outcome measure(s) 1. Reduction in anaemia
2. Change in cognitive performance
Secondary outcome measure(s) Number of clinical malaria episodes during trial period
Sources of funding The Medicor Foundation (Liechtenstein)
Trial website
Publications 1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18028969
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20107144
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20962160
Contact name Dr  Michael B.  Zimmermann
  Address ETH Food Science and Nutrition
Human Nutrition Laboratory, LFV E 19
Schmelzbergstrasse 7
  City/town Zurich
  Zip/Postcode 8092
  Country Switzerland
  Tel +41 (0)44 632-8657
  Fax +41 (0)44 632-1470
  Email michael.zimmermann@ilw.agrl.ethz.ch
Sponsor ETH Food Science and Nutrition (Switzerland)
  Address c/o Richard F. Hurrell
Human Nutrition Laboratory
LFV D 20
Schmelzbergstrasse 7
  City/town Zurich
  Zip/Postcode 8092
  Country Switzerland
  Tel +41 (0)44 632-8420
  Fax +41 (0)44 632-1470
  Email richard.hurrell@ilw.agrl.ethz.ch
  Sponsor website: http://www.ethz.ch/
Date applied 18/11/2006
Last edited 25/08/2011
Date ISRCTN assigned 21/11/2006
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