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.

Sponsors

Lead Sponsor: Swiss Federal Institute of Technology

Collaborator: Swiss Tropical & Public Health Institute
Swiss National Science Foundation

Source 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.

Overall Status Completed
Start Date April 2012
Completion Date May 2013
Primary Completion Date May 2013
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Hemoglobin 9 months
Secondary Outcome
Measure Time Frame
Iron status indicators (SF, TfR) 9 months
Malaria prevalence 9 months
Enrollment 629
Condition
Intervention

Intervention Type: Drug

Intervention Name: SP/amodiaquine

Description: 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.

Arm Group Label: IPT of malaria

Intervention Type: Dietary Supplement

Intervention Name: FeFum fortified porridge

Description: 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.

Arm Group Label: FeFum porridge

Intervention Type: Drug

Intervention Name: SP/Amodiaquine + FeFum fortified porridge

Description: 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.

Arm Group Label: FeFum porridge + IPT of malaria

Intervention Type: Dietary Supplement

Intervention Name: Ferric pyrophosphate fortified porridge

Description: 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.

Arm Group Label: FePP porridge

Intervention Type: Other

Intervention Name: Placebo

Description: Placebo of SP/Amodiaquine every 3 months for 9 months. No dietary intervention.

Arm Group Label: Placebo

Eligibility

Criteria:

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

Gender: All

Minimum Age: 12 Months

Maximum Age: 36 Months

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Rita Wegmüller, Doctor Principal Investigator Swiss Federal Institute of Technology
Location
Facility: Hopital General de Taabo Cite
Location Countries

Côte D'Ivoire

Verification Date

September 2013

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Swiss Federal Institute of Technology

Investigator Full Name: Prof. Michael B. Zimmermann

Investigator Title: Prof

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

Label: Placebo

Type: Placebo Comparator

Description: Placebo

Label: FeFum porridge + IPT of malaria

Type: Experimental

Label: IPT of malaria

Type: Experimental

Label: FeFum porridge

Type: Experimental

Label: FePP porridge

Type: Experimental

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Basic Science

Masking: Single (Participant)

Source: ClinicalTrials.gov