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

Federal Institute of Technology (ETH) Zurich

Status: Completed

Conditions: Anemia

Treatments: Other: Placebo; Dietary Supplement: Ferric pyrophosphate fortified porridge; Dietary Supplement: FeFum fortified porridge; Drug: SP/Amodiaquine + FeFum fortified porridge; Drug: SP/amodiaquine

Study type: Interventional

Funder types: Other

Identifiers

NCT01634945

IZ70Z0_123900/1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 629 patients

Sex: All

Ages: 12 to 36 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

629 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo

FeFum porridge + IPT of malaria

Experimental group

Treatment:

Drug: SP/Amodiaquine + FeFum fortified porridge

IPT of malaria

Experimental group

Treatment:

Drug: SP/amodiaquine

FeFum porridge

Experimental group

Treatment:

Dietary Supplement: FeFum fortified porridge

FePP porridge

Experimental group

Treatment:

Dietary Supplement: Ferric pyrophosphate fortified porridge