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

NCT ID: NCT01634945

Last Updated: 2013-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

629 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-05-31

Brief Summary

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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

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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.

Conditions

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Anemia

Keywords

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anemia malaria malnutrition iron fortification intermittent preventive treatment subsaharan africa ivory coast young children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

FeFum porridge + IPT of malaria

Group Type EXPERIMENTAL

SP/Amodiaquine + FeFum fortified porridge

Intervention Type DRUG

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.

IPT of malaria

Group Type EXPERIMENTAL

SP/amodiaquine

Intervention Type DRUG

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.

FeFum porridge

Group Type EXPERIMENTAL

FeFum fortified porridge

Intervention Type DIETARY_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.

FePP porridge

Group Type EXPERIMENTAL

Ferric pyrophosphate fortified porridge

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DRUG

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss Tropical & Public Health Institute

OTHER

Sponsor Role collaborator

Swiss National Science Foundation

OTHER

Sponsor Role collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Prof. Michael B. Zimmermann

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rita Wegmüller, Doctor

Role: PRINCIPAL_INVESTIGATOR

Swiss Federal Institute of Technology

Locations

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Hopital General de Taabo Cite

Taabo Cite, , Côte d’Ivoire

Site Status

Countries

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Côte d’Ivoire

References

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Glinz D, Wegmuller R, Ouattara M, Diakite VG, Aaron GJ, Hofer L, Zimmermann MB, Adiossan LG, Utzinger J, N'Goran EK, Hurrell RF. Iron Fortified Complementary Foods Containing a Mixture of Sodium Iron EDTA with Either Ferrous Fumarate or Ferric Pyrophosphate Reduce Iron Deficiency Anemia in 12- to 36-Month-Old Children in a Malaria Endemic Setting: A Secondary Analysis of a Cluster-Randomized Controlled Trial. Nutrients. 2017 Jul 14;9(7):759. doi: 10.3390/nu9070759.

Reference Type DERIVED
PMID: 28708072 (View on PubMed)

Glinz D, Hurrell RF, Ouattara M, Zimmermann MB, Brittenham GM, Adiossan LG, Righetti AA, Seifert B, Diakite VG, Utzinger J, N'Goran EK, Wegmuller R. The effect of iron-fortified complementary food and intermittent preventive treatment of malaria on anaemia in 12- to 36-month-old children: a cluster-randomised controlled trial. Malar J. 2015 Sep 17;14:347. doi: 10.1186/s12936-015-0872-3.

Reference Type DERIVED
PMID: 26377199 (View on PubMed)

Other Identifiers

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IZ70Z0_123900/1

Identifier Type: -

Identifier Source: org_study_id