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

Swiss Federal Institute of Technology629 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

629

Conditions

Anemia

Interventions

SP/amodiaquineDRUG

FeFum fortified porridgeDIETARY_SUPPLEMENT

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.

SP/Amodiaquine + FeFum fortified porridgeDRUG

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.

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 36 Months

Medical Language ↔ Plain English

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

Locations (1)

Hopital General de Taabo Cite

Taabo Cite, Côte d’Ivoire

Outcomes

Primary Outcomes

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.

Time frame: 9 months

Secondary Outcomes

Iron status indicators (SF, TfR)

The study population will consist of 12 to 36-month-old infants in villages covered by the Taabo DSS site.

Time frame: 9 months

Malaria prevalence

The study population will consist of 12 to 36-month-old infants in villages covered by the Taabo DSS site.

Time frame: 9 months

Data from ClinicalTrials.gov

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