Efficacy of Iron Fortified Complementary Food and IPT of Malaria in Young Children in Côte d'Ivoire

Not Applicable

Completed

• Conditions: Anemia
• Interventions: Dietary Supplement: Ferric pyrophosphate fortified porridge; Other: Placebo; Drug: SP/Amodiaquine + FeFum fortified porridge; Drug: SP/amodiaquine; Dietary Supplement: FeFum fortified porridge

• Registration Number: NCT01634945
• Lead Sponsor: Swiss Federal Institute of Technology

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.

Detailed Description

Efficacy study - ANAEMIA project Côte d'Ivoire 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. The fortified product will be provided as porridge (Nutribon produced by PKL) with an optimized formula (2 mg in the form of NaFeEDTA and 3.8 mg in the form of ferrous fumarate) of the premix. In addition, we will assess the Nutribon product currently available on the market and we will compare it to an optimized premix formula. The current and the optimized formula contain each 2 mg iron in the form of NaFeEDTA. In addition to the NaFeEDTA the current premix contains 3.8 mg in the form of ferric pyrophosphate, which is less bioavailable than the 3.8 mg ferrous fumarate in the optimized formula. The study will be carried out between May and December 2012 which includes the rainy season (April - October) with its two peaks in Côte d'Ivoire and thus the period when malaria transmission is highest. The study will be implemented in a Health and Demographic Surveillance System in Taabo in Côte d'Ivoire and comprise 625 children between 12 to 36 months. 375 eligible infants will receive a fortified porridge (250 with the improved formula and 125 with the current formula), whereas 250 infants will continue with their local diet (control group). Infants receiving the optimized formula and infants in the control group will be randomly assigned to IPT of malaria (125 in each group) or placebo (125 in each group). Thus, infants can be assigned to one of the following five groups: 1. group (n=125): fortified porridge (optimized formula) and IPT of malaria 2. group (n=125): fortified porridge (optimized formula) and placebo 3. group (n=125): local diet and IPT of malaria and 4. group (n=125): local diet and placebo. 5. group (n=125): fortified porridge (current formula) and placebo, representing the current situation in Côte d'Ivoire in infants consuming fortified complementary food. This efficacy trial will deepen our understanding in preventing anaemia and the interaction of bioavailable iron compounds with an antimalarial drug and related conditions in very young children. Further, the study should demonstrate whether the earlier study failed to show an impact on anaemia due to the use of an iron compound that lacked bioavailability and/or using an antimalarial drug in the IPT intervention arm that lacked efficacy perhaps due to resistance by P. falciparum, or other yet to be investigated causes.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-03
• Study First Posted: 2012-07-06
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-23
• Last Update Posted: 2013-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 629

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FePP porridge	Ferric pyrophosphate fortified porridge	-
Placebo	Placebo	Placebo
FeFum porridge + IPT of malaria	SP/Amodiaquine + FeFum fortified porridge	-
IPT of malaria	SP/amodiaquine	-
FeFum porridge	FeFum fortified porridge	-

Primary Outcome Measures

Name	Time	Method
Hemoglobin	9 months	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.

Secondary Outcome Measures

Name	Time	Method
Iron status indicators (SF, TfR)	9 months	The study population will consist of 12 to 36-month-old infants in villages covered by the Taabo DSS site.
Malaria prevalence	9 months	The study population will consist of 12 to 36-month-old infants in villages covered by the Taabo DSS site.

Trial Locations

Locations (1)

Hopital General de Taabo Cite; 🇨🇮 Taabo Cite, Côte D'Ivoire