Condition category
Infections and Infestations
Date applied
09/11/2012
Date assigned
29/11/2012
Last edited
21/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Anaemia is caused when there aren’t enough red blood cells or haemoglobin (the part of the red blood cell that carries oxygen) to meet the body’s needs. Anaemia affects more than two billion people worldwide and is a huge public health problem in developing countries. For instance, it is currently estimated that in Africa, about half of the children and women of childbearing age are at risk of anaemia. It is commonly thought that lack of iron is the main cause for anaemia. However, anaemia can result from other diet deficiencies, as well as from parasitic diseases such as malaria and helminthiases (worm infection), or from genetic disorders such as haemoglobinopathies. The aim of this study is to find out which factors (e.g., nutrient deficiencies, parasitic infections) are associated with anaemia in different population groups in a typical rural setting of Côte d’Ivoire, West Africa.

Who can participate?
Infants (aged 6-23 months), young school-aged children (aged 6-8 years) and young women (aged 15-25 years) living in one of the three selected localities

What does the study involve?
Participants are assessed to see how haemoglobin concentration changes over time in response to specific health interventions (e.g., treatments and preventive chemotherapy against soil-transmitted helminthiasis and schistosomiasis, and treatments of clinical malaria and severe anaemia cases). Additionally, the prevalence of haemoglobinopathies (genetic defect that affects haemoglobin) is determined in the study area. The participants undergo tests, namely examination of blood, urine and faeces samples for parasites, and haemoglobin measurements. These tests are conducted at the start of the study and at four further follow-up surveys once every 3-4 months. Moreover, a blood sample is collected at the start of the study, after 6 months and at the end-of-study survey.

What are the possible benefits and risks of participating?
Findings from this study will increase knowledge about anaemia in West Africa, which might lead to suggestions on how to locally better prevent and control anaemia. Participants are examined regularly over a 14-month period by qualified medical staff. Participants are treated if a clinical malaria episode or a helminth infection is diagnosed, according to national guidelines. These treatments might result in some adverse events, which are usually brief. All personnel who perform the medical examinations and treatment are qualified and well experienced (i.e. medical doctors, nurses and technicians who are well acquainted to do this type of work). All methods applied within the study are routinely used in the field, the laboratories and the hospitals and therefore do not place participants under any specific risk. Particular care is taken when sampling blood, as there are small risks such as bruise, infection and/or inflammation of the vein, and discomfort at the time of taking a blood sample. These risks are minimized by doing the blood collection with all the precautions using sterile material and performed only by experienced staff.

Where is the study run from?
Taabo HDSS (Côte d’Ivoire)

When is the study starting and how long is it expected to run for?
April 2010 to June 2011

Who is funding the study?
Swiss National Science Foundation (Switzerland)

Who is the main contact?
Prof. Jürg Utzinger
juerg.utzinger@unibas.ch

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jürg Utzinger

ORCID ID

Contact details

Swiss Tropical and Public Health Institute
Department of Epidemiology and Public Health
Basel
CH-4002
Switzerland
+41 (0)61 284-8129
juerg.utzinger@unibas.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Aetiology of anaemia and public health implications in the Taabo health demographic surveillance system, south-central Côte d’Ivoire

Acronym

Study hypothesis

Anaemia is associated with sociodemographic variables, micronutrient deficiencies, parasitic infections and inflammatory parameters and these associations depend on the host age and sex.

Ethics approval

1. Ethikkommission beider Basel (EKBB), Switzerland, 10/10/2010, ref: 252/09 (Amendment - 17/04/2010)
2. Comité National d’Éthique et de la Recherche, Ministère de la Santé et de l’Hygiène publique, 23/03/2010, ref: 1086 MSHP/CNER

Study design

Prospective longitudinal trials

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Anaemia, malaria, helminth infection

Intervention

Non-pregnant participants who were diagnosed with soil-transmitted helminths at the baseline or at one of the four further follow-up surveys:
1. Single-dose albendazole (400 mg for school-aged children and women and 200 mg for infants)
Participants who were diagnosed with Schistosoma mansoni or S. haematobium at the baseline or at one of the four further follow-up surveys:
2. Single-dose praziquantel (40 mg/kg for children >2 years old)
Suspected clinical malaria cases (defined by a positive rapid diagnostic test (RDT) and tympanic temperature >38°C):
3. artesunate-amodiaquine (infants: 25 mg + 67.5 mg/day for 3 days; children: 100 mg + 270 mg/day for 3 days; women: 2 x 100 mg + 270 mg/day for 3 days)
Severely anaemic participants (i.e., haemaglobin level <8 g/dl, according to national guidelines of Côte d’Ivoire) with a positive RDT for malaria
4. treatment with artesunate-amodiaquine or referral to the nearest health center if their RDT is negative.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Haemoglobin concentration

Secondary outcome measures

1. Iron status indicators
2. Parasitic infection variables

Overall trial start date

15/04/2010

Overall trial end date

28/06/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Infants, aged 6-23 months (males and females); children aged 6-8 years (males and females); and women aged 15-25 years at the baseline cross-sectional survey
2. Participants will be randomly selected from an existing database kept by the Taabo HDSS
3. Written informed consent (or fingerprint for illiterate people) of school-aged children, women and a parent/guardian of infants and school-aged children at baseline or at one of the four further cross-sectional surveys
4. Written approval of the study physician

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

Approximately 750

Participant exclusion criteria

People who are severely ill, as judged by the study physician.

Recruitment start date

15/04/2010

Recruitment end date

28/06/2011

Locations

Countries of recruitment

Cote d'Ivoire

Trial participating centre

Swiss Tropical and Public Health Institute
Basel
CH-4002
Switzerland

Sponsor information

Organisation

Swiss National Science Foundation (SNSF) (Switzerland)

Sponsor details

Wildhainweg 3
PO Box 8232
Bern
CH-3001
Switzerland

Sponsor type

Government

Website

http://www.snf.ch/

Funders

Funder type

Government

Funder name

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (ref: IZ70Z0_123900)

Alternative name(s)

Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Switzerland

Funder name

Eremitage Fund of the Rudolf Geigy-Foundation (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fairmed (Switzerland)

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

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23133691
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22848097
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23615827

Publication citations

  1. Results

    Righetti AA, Glinz D, Adiossan LG, Koua AY, Niamké S, Hurrell RF, Wegmüller R, N'Goran EK, Utzinger J, Interactions and potential implications of Plasmodium falciparum-hookworm coinfection in different age groups in south-central Côte d'Ivoire., PLoS Negl Trop Dis, 2012, 6, 11, e1889, doi: 10.1371/journal.pntd.0001889.

  2. Results

    Righetti AA, Koua AY, Adiossan LG, Glinz D, Hurrell RF, N'goran EK, Niamké S, Wegmüller R, Utzinger J, Etiology of anemia among infants, school-aged children, and young non-pregnant women in different settings of South-Central Cote d'Ivoire., Am. J. Trop. Med. Hyg., 2012, 87, 3, 425-434, doi: 10.4269/ajtmh.2012.11-0788.

  3. Results

    Righetti AA, Wegmüller R, Glinz D, Ouattara M, Adiossan LG, N'Goran EK, Utzinger J, Hurrell RF, Effects of inflammation and Plasmodium falciparum infection on soluble transferrin receptor and plasma ferritin concentration in different age groups: a prospective longitudinal study in Côte d'Ivoire., Am. J. Clin. Nutr., 2013, 97, 6, 1364-1374, doi: 10.3945/ajcn.112.050302.

Additional files

Editorial Notes

21/10/2016: Plain English summary added.