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Completed

NCT Number: NCT01092377

The Effects of Iron and Omega-3 Fatty Acid Supplementation on Cognition and Immune Function in Iron Deficient 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.

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Key information

Conditions

Iron Deficiency Anemia Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Valley of a Thousand Hills

Botha’s Hill, KwaZulu-Natal, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DHA and EPA Fish Oil capsule

Dietary Supplement

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)

Iron tablet

Dietary Supplement

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)

Placebo tablet

Other

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 capsule

Other

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)

Primary outcomes

  1. Change in cognitive and behavioral performance and immune function

    Time frame: 8 months

Secondary outcomes

  1. Change in activity levels, gut microbiota, iron status, fatty acid status and gene expression

    Time frame: 8 months

Sponsors and collaborators

Lead sponsor

North-West University, South Africa

Other

Collaborators

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

Registry information

Official study title

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

Acronym: FeFA

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 24, 2010
Registry last updated
Jan 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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