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

Anemia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01634945
• Other study ID #: IZ70Z0_123900/1
• Status: Completed
• Phase: N/A
• First received: July 3, 2012
• Last updated: September 23, 2013
• Start date: April 2012
• Est. completion date: May 2013

Study information

• Verified date: September 2013
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: ETH ZürichSwitzerland: Swiss Tropical and Public Health InstitutIvory Coast: Centre Suisse des Recherches Scientifiques en Côte d'IvoireIvory Coast: Université de Cocody-AbidjanIvory Coast: National Research and Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 629
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 36 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anemia

Intervention

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.

Locations

Country	Name	City	State
Côte D'Ivoire	Hopital General de Taabo Cite	Taabo Cite

Sponsors (3)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Swiss National Science Foundation, Swiss Tropical & Public Health Institute

Country where clinical trial is conducted

Côte D'Ivoire, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin	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	No
Secondary	Iron status indicators (SF, TfR)	The study population will consist of 12 to 36-month-old infants in villages covered by the Taabo DSS site.	9 months	No
Secondary	Malaria prevalence	The study population will consist of 12 to 36-month-old infants in villages covered by the Taabo DSS site.	9 months	No