Condition category
Haematological Disorders
Date applied
18/11/2006
Date assigned
21/11/2006
Last edited
25/08/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ethz.ch/

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes