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

ISRCTN ISRCTN21782274
DOI https://doi.org/10.1186/ISRCTN21782274
Secondary identifying numbers PPOOB--102883
Submission date
18/11/2006
Registration date
21/11/2006
Last edited
25/08/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study designRandomised, double-blind, clinical trial (2 x 2 x 2 factorial design)
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific title
Study acronymIronSPAlbenPrazi
Study objectivesIron 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) studiedMild to moderate anaemia
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Iron fortification, sulfadoxine, pyrimethamine, albendazole and praziquantel
Primary outcome measure1. Reduction in anaemia
2. Change in cognitive performance
Secondary outcome measuresNumber of clinical malaria episodes during trial period
Overall study start date27/11/2006
Completion date31/08/2007

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Years
Upper age limit14 Years
SexBoth
Target number of participants640
Key inclusion criteria1. 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 criteria1. 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 enrolment27/11/2006
Date of final enrolment31/08/2007

Locations

Countries of recruitment

  • Côte d'Ivoire
  • Switzerland

Study participating centre

ETH Food Science and Nutrition
Zurich
8092
Switzerland

Sponsor information

ETH Food Science and Nutrition (Switzerland)
Government

c/o Richard F. Hurrell
Human Nutrition Laboratory
LFV D 20
Schmelzbergstrasse 7
Zurich
8092
Switzerland

Phone +41 (0)44 632-8420
Email richard.hurrell@ilw.agrl.ethz.ch
Website http://www.ethz.ch/
ROR logo "ROR" https://ror.org/05a28rw58

Funders

Funder type

Industry

The Medicor Foundation (Liechtenstein)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added 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