The Effects of Iron and Omega-3 Fatty Acid Supplementation on Cognition and Immune Function in Iron Deficient Children (FeFA)

January 13, 2011 updated by: North-West University, South Africa

The Effects of Iron and Omega-3 Fatty Acid Supplementation, Alone and in Combination, on Cognition, Immune System and Gut Microbiota: a Randomized, Double-blind, 2x2 Intervention Trial in Iron Deficient South African Children

The aim of this study is to determine if providing iron and a mixture of DHA and EPA, alone and in combination, to children with iron deficiency and poor n-3 fatty acid intake will improve their cognitive performance, activity levels and immune system.

Additionally, the effects on iron and fatty acid status, and gut microbiota, will be assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In populations of low socio economic status, such as found in South Africa, iron deficiency coexisting with a low intake of n-3 fatty acids could synergistically compromise both the intellectual performance and immune system of children.

Therefore, specific cognitive processes (domains) and specific immunization status markers and immune function modulators, that have been found to be affected by iron and n-3 fatty acid deficiency in children in previous studies will be assessed.

This will be the first human study that assesses the interactions of iron and n-3 fatty acid supplementation to iron deficient children in a two-by-two factorial, randomized, double-blind, placebo-controlled trial.

Study Type

Interventional

Enrollment (Actual)

320

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

  • South Africa
    • KwaZulu-Natal
      • Botha's Hill, KwaZulu-Natal, South Africa
        • Valley of a Thousand Hills

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

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 6-10 years
  • Iron deficiency (Serum ferritin < 20 µg/L or zinc protoporphyrin > 70 µmol/mol heme in washed erythrocytes or TfR > 8.3 mg/L) with no or mild anaemia

Exclusion Criteria:

  • Chronic illness
  • Severe anemia (Hb < 80 g/L)
  • Use of iron or n-3 fatty acid containing supplements

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: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DHA/EPA capsules and iron tablet
Dietary supplement: DHA and EPA Fish Oil capsule
2 DHA/EPA capsules on 4 days per week containing totally 420 mg DHA and 80 mg EPA, providing an average dose of 285.7 mg n-3 fatty acids per day
Other Names:
  • Provided by Burgerstein AG (Rapperswil, Switzerland)
Dietary supplement: Iron tablet
1 iron tablet containing 50 mg of iron as ferrous sulfate will be administered on 4 days per week, providing an average iron dose of 28.6 mg iron per day.
Other Names:
  • Provided by Lomapharm (Paul Lohmann GmbH, Emmertal, Germany)
Experimental: DHA/EPA and placebo tablet
Dietary supplement: DHA and EPA Fish Oil capsule
2 DHA/EPA capsules on 4 days per week containing totally 420 mg DHA and 80 mg EPA, providing an average dose of 285.7 mg n-3 fatty acids per day
Other Names:
  • Provided by Burgerstein AG (Rapperswil, Switzerland)
Other: Placebo tablet
Placebo tablet will be administered on 4 days per week and will be identical in appearance to the iron tablet.
Other Names:
  • Provided by Lomapharm (Paul Lohmann GmbH, Emmertal, Germany)
Placebo Comparator: placebo capsules & placebo tablet
Dietary supplement: Iron tablet
1 iron tablet containing 50 mg of iron as ferrous sulfate will be administered on 4 days per week, providing an average iron dose of 28.6 mg iron per day.
Other Names:
  • Provided by Lomapharm (Paul Lohmann GmbH, Emmertal, Germany)
Other: Placebo tablet
Placebo tablet will be administered on 4 days per week and will be identical in appearance to the iron tablet.
Other Names:
  • Provided by Lomapharm (Paul Lohmann GmbH, Emmertal, Germany)
Other: Placebo capsule
Placebo capsules contain medium chain triglycerides and will be identical in appearance and total fat content to the DHA/EPA capsules.
Other Names:
  • Will be provided by R.P. Scherer GmbH (Eberbach, Germany)
Experimental: iron tablet and placebo capsules
Other: Placebo capsule
Placebo capsules contain medium chain triglycerides and will be identical in appearance and total fat content to the DHA/EPA capsules.
Other Names:
  • Will be provided by R.P. Scherer GmbH (Eberbach, Germany)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in cognitive and behavioral performance and immune function
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in activity levels, gut microbiota, iron status, fatty acid status and gene expression
Time Frame: 8 months
8 months

Collaborators and Investigators

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

Sponsor

North-West University, South Africa

Collaborators

Medical Research Council, South Africa
Swiss Federal Institute of Technology
Unilever R&D

Investigators

  • Study Director: Marius Smuts, PhD, North-West University
  • Study Director: Michael B Zimmermann, PhD, ETH Zurich
  • Principal Investigator: Linda Malan, MSc, North-West University
  • Principal Investigator: Jeannine Baumgartner, MSc, ETH Zurich

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

February 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

March 23, 2010

First Submitted That Met QC Criteria

March 23, 2010

First Posted (Estimate)

March 24, 2010

Study Record Updates

Last Update Posted (Estimate)

January 14, 2011

Last Update Submitted That Met QC Criteria

January 13, 2011

Last Verified

December 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FeFA study 2010

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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