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 dIvoire
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 dÉthique et de la Recherche, Ministère de la Santé et de lHygiène 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 dIvoire) 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 measure
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 (if study stopped)
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
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, SNSF, FNS, SNF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
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
Basic results (scientific)
Publication list
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
-
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.
-
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.
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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.