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

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.

Conditions

• Anemia

Interventions

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.

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.

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.

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.

OTHER

Placebo

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

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute

  collaborator OTHER

• Swiss National Science Foundation

  collaborator OTHER

• Swiss Federal Institute of Technology

  lead OTHER

Principal Investigators

• Rita Wegmüller, Doctor · Swiss Federal Institute of Technology

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

12 Months

Max Age

36 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-04-30

Primary Completion

2013-05-31

Completion

2013-05-31

Countries

• Côte d’Ivoire