Efficacy of Iron Fortified Complementary Food and IPT of Malaria in Young Children in Côte d'Ivoire
Aetiology, Prevention and Control of Anaemia in Sub-Saharan Africa - Work Package 2: Efficacy Study: Efficacy of 2 Iron Fortified Porridges and IPT for the Prevention of Anemia in Young Children in Côte d'Ivoire.
1 other identifier
interventional
629
1 country
1
Brief Summary
The proposed project is aimed at testing two interventions, namely a highly bioavailable iron compound and a combination of SP plus amodiaquine for intermittent preventive treatment (IPT) of malaria, to reduce anaemia in very young children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 3, 2012
CompletedFirst Posted
Study publicly available on registry
July 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedSeptember 24, 2013
September 1, 2013
1.1 years
July 3, 2012
September 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin
The study population will consist of 12 to 36-month-old infants in villages covered by the Taabo DSS site. Assuming a mean Hb of 97.3±19.6 g/l and that an increase of 8 g/l in Hb would be clinically relevant, and allowing for a dropout rate of 20%, we calculated that 125 infants per group were initially needed to achieve a power level of 90% at a 5% level of significance.
9 months
Secondary Outcomes (2)
Iron status indicators (SF, TfR)
9 months
Malaria prevalence
9 months
Study Arms (5)
Placebo
PLACEBO COMPARATORPlacebo
FeFum porridge + IPT of malaria
EXPERIMENTALIPT of malaria
EXPERIMENTALFeFum porridge
EXPERIMENTALFePP porridge
EXPERIMENTALInterventions
One dose of SP (500 mg sulfadoxine plus 25 mg pyrimethamine, or half of the dose if body weight =\< 10 kg) and three daily doses of Amodiaquine (1. Day: 200 mg, 2. Day: 200 mg and 3. Day: 100 mg, or half of the dose each day if body weight =\< 10 kg), every three months, i.e. 3 times during 9 consecutive months.
6 times per week supply of iron fortified porridge (25 g portion containing 5.8 mg of iron: 2 mg as NaFeEDTA + 3.8 mg as ferrous fumarate) for 9 months.
One dose of SP (500 mg sulfadoxine plus 25 mg pyrimethamine, or half of the dose if body weight =\< 10 kg) and three daily doses of Amodiaquine (1. Day: 200 mg, 2. Day: 200 mg and 3. Day: 100 mg, or half of the dose each day if body weight =\< 10 kg), every three months, i.e. 3 times during 9 consecutive months. 6 times per week supply of iron fortified porridge (25 g portion containing 5.8 mg of iron: 2 mg as NaFeEDTA + 3.8 mg as ferrous fumarate) for 9 months.
6 days per week supply of iron fortified porridge (25 g portion containing 5.8 mg of iron: 2 mg as NaFeEDTA + 3.8 mg as ferric pyrophosphate) for 9 months.
Eligibility Criteria
You may qualify if:
- Children, aged 12 - 36 months, both sexes
- Absence of major systemic illnesses (as assessed by medical doctor upon initial full clinical assessment)
- Registered in DSS Taabo and anticipated residence in the study area for at least 1 year
- No severe anaemia, i.e. Hb ≥70 g/L in infants, as assessed by a Coulter Counter device
- No known or reported hypersensitivity to sulfadoxine-pyrimethamine, amodiaquine
- No known or reported history of significant chronic illness
- Written informed consent of parents or legal guardian
You may not qualify if:
- severe anaemia, i.e. Hb ≥70 g/L in infants, as assessed by a Coulter Counter device
- major systemic illnesses (as assessed by medical doctor upon initial full clinical assessment)
- known or reported hypersensitivity to albendazole, sulfadoxine-pyrimethamine, amodiaquine
- known or reported history of significant chronic illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Swiss Federal Institute of Technologylead
- Swiss Tropical & Public Health Institutecollaborator
- Swiss National Science Foundationcollaborator
Study Sites (1)
Hopital General de Taabo Cite
Taabo Cite, Côte d’Ivoire
Related Publications (2)
Glinz D, Wegmuller R, Ouattara M, Diakite VG, Aaron GJ, Hofer L, Zimmermann MB, Adiossan LG, Utzinger J, N'Goran EK, Hurrell RF. Iron Fortified Complementary Foods Containing a Mixture of Sodium Iron EDTA with Either Ferrous Fumarate or Ferric Pyrophosphate Reduce Iron Deficiency Anemia in 12- to 36-Month-Old Children in a Malaria Endemic Setting: A Secondary Analysis of a Cluster-Randomized Controlled Trial. Nutrients. 2017 Jul 14;9(7):759. doi: 10.3390/nu9070759.
PMID: 28708072DERIVEDGlinz D, Hurrell RF, Ouattara M, Zimmermann MB, Brittenham GM, Adiossan LG, Righetti AA, Seifert B, Diakite VG, Utzinger J, N'Goran EK, Wegmuller R. The effect of iron-fortified complementary food and intermittent preventive treatment of malaria on anaemia in 12- to 36-month-old children: a cluster-randomised controlled trial. Malar J. 2015 Sep 17;14:347. doi: 10.1186/s12936-015-0872-3.
PMID: 26377199DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rita Wegmüller, Doctor
Swiss Federal Institute of Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
July 3, 2012
First Posted
July 6, 2012
Study Start
April 1, 2012
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
September 24, 2013
Record last verified: 2013-09