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

September 23, 2013 updated by: Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

629

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Côte D'Ivoire
      • Taabo Cite, Côte D'Ivoire
        • Hopital General de Taabo Cite

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Placebo of SP/Amodiaquine every 3 months for 9 months. No dietary intervention.
Experimental: FeFum porridge + IPT of malaria
Drug: SP/Amodiaquine + FeFum fortified porridge

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.
Experimental: IPT of malaria
Drug: SP/amodiaquine
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.
Experimental: FeFum porridge
Dietary supplement: FeFum fortified porridge
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.
Experimental: FePP porridge
Dietary supplement: Ferric pyrophosphate fortified porridge
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin
Time Frame: 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.
9 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Federal Institute of Technology

Collaborators

Swiss National Science Foundation
Swiss Tropical & Public Health Institute

Investigators

  • Principal Investigator: Rita Wegmüller, Doctor, Swiss Federal Institute of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

July 3, 2012

First Submitted That Met QC Criteria

July 3, 2012

First Posted (Estimate)

July 6, 2012

Study Record Updates

Last Update Posted (Estimate)

September 24, 2013

Last Update Submitted That Met QC Criteria

September 23, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IZ70Z0_123900/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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