Contact information
Type
Scientific
Primary contact
Dr Michael B. Zimmermann
ORCID ID
Contact details
ETH Food Science and Nutrition
Human Nutrition Laboratory
LFV E 19
Schmelzbergstrasse 7
Zurich
8092
Switzerland
+41 (0)44 632-8657
michael.zimmermann@ilw.agrl.ethz.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PPOOB--102883
Study information
Scientific title
Acronym
IronSPAlbenPrazi
Study hypothesis
Iron fortification, intermittent preventive treatment for malaria, and regular anti-helmintic treatment - alone and in combination - reduce anaemia in schoolchildren.
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)
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
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 names
Iron fortification, sulfadoxine, pyrimethamine, albendazole and praziquantel
Primary outcome measures
1. Reduction in anaemia
2. Change in cognitive performance
Secondary outcome measures
Number of clinical malaria episodes during trial period
Overall trial start date
27/11/2006
Overall trial end date
31/08/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
640
Participant 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
Recruitment start date
27/11/2006
Recruitment end date
31/08/2007
Locations
Countries of recruitment
Cote d'Ivoire
Trial participating centre
ETH Food Science and Nutrition
Zurich
8092
Switzerland
Sponsor information
Organisation
ETH Food Science and Nutrition (Switzerland)
Sponsor details
c/o Richard F. Hurrell
Human Nutrition Laboratory
LFV D 20
Schmelzbergstrasse 7
Zurich
8092
Switzerland
+41 (0)44 632-8420
richard.hurrell@ilw.agrl.ethz.ch
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
The Medicor Foundation (Liechtenstein)
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
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
Publication citations
-
Results
Utzinger J, Rinaldi L, Lohourignon LK, Rohner F, Zimmermann MB, Tschannen AB, N'goran EK, Cringoli G, FLOTAC: a new sensitive technique for the diagnosis of hookworm infections in humans., Trans. R. Soc. Trop. Med. Hyg., 2008, 102, 1, 84-90, doi: 10.1016/j.trstmh.2007.09.009.
-
Results
Rohner F, Zimmermann MB, Amon RJ, Vounatsou P, Tschannen AB, N'goran EK, Nindjin C, Cacou MC, Té-Bonlé MD, Aka H, Sess DE, Utzinger J, Hurrell RF, In a randomized controlled trial of iron fortification, anthelmintic treatment, and intermittent preventive treatment of malaria for anemia control in Ivorian children, only anthelmintic treatment shows modest benefit., J. Nutr., 2010, 140, 3, 635-641, doi: 10.3945/jn.109.114256.
-
Results
Zimmermann MB, Chassard C, Rohner F, N'goran EK, Nindjin C, Dostal A, Utzinger J, Ghattas H, Lacroix C, Hurrell RF, The effects of iron fortification on the gut microbiota in African children: a randomized controlled trial in Cote d'Ivoire., Am. J. Clin. Nutr., 2010, 92, 6, 1406-1415, doi: 10.3945/ajcn.110.004564.