Iron fortification and parasite control to reduce anaemia among schoolchildren in Cote d'Ivoire
ISRCTN | ISRCTN21782274 |
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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
Scientific
ETH Food Science and Nutrition
Human Nutrition Laboratory, LFV E 19
Schmelzbergstrasse 7
Zurich
8092
Switzerland
Phone | +41 (0)44 632-8657 |
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michael.zimmermann@ilw.agrl.ethz.ch |
Study information
Study design | Randomised, double-blind, clinical trial (2 x 2 x 2 factorial design) |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Prevention |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Iron fortification, sulfadoxine, pyrimethamine, albendazole and praziquantel |
Primary outcome measure | 1. Reduction in anaemia 2. Change in cognitive performance |
Secondary outcome measures | Number of clinical malaria episodes during trial period |
Overall study start date | 27/11/2006 |
Completion date | 31/08/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 6 Years |
Upper age limit | 14 Years |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- Côte d'Ivoire
- Switzerland
Study participating centre
ETH Food Science and Nutrition
Zurich
8092
Switzerland
8092
Switzerland
Sponsor information
ETH Food Science and Nutrition (Switzerland)
Government
Government
c/o Richard F. Hurrell
Human Nutrition Laboratory
LFV D 20
Schmelzbergstrasse 7
Zurich
8092
Switzerland
Phone | +41 (0)44 632-8420 |
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richard.hurrell@ilw.agrl.ethz.ch | |
Website | http://www.ethz.ch/ |
https://ror.org/05a28rw58 |
Funders
Funder type
Industry
The Medicor Foundation (Liechtenstein)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |