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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Iron Deficiency, Anemia

Intervention / Treatment
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* Dietary Supplement: DHA and EPA Fish Oil capsule
* Dietary Supplement: Iron tablet
* Other: Placebo tablet
* Other: Placebo capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DHA/EPA capsules and iron tablet<br> | Dietary Supplement: DHA and EPA Fish Oil capsule<br>* 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<br>* Other names: Provided by Burgerstein AG (Rapperswil, Switzerland);Dietary Supplement: Iron tablet<br>* 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.<br>* Other names: Provided by Lomapharm (Paul Lohmann GmbH, Emmertal, Germany);|
| Experimental: DHA/EPA and placebo tablet<br> | Dietary Supplement: DHA and EPA Fish Oil capsule<br>* 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<br>* Other names: Provided by Burgerstein AG (Rapperswil, Switzerland);Other: Placebo tablet<br>* Placebo tablet will be administered on 4 days per week and will be identical in appearance to the iron tablet.<br>* Other names: Provided by Lomapharm (Paul Lohmann GmbH, Emmertal, Germany);|
| Placebo Comparator: placebo capsules & placebo tablet<br> | Dietary Supplement: Iron tablet<br>* 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.<br>* Other names: Provided by Lomapharm (Paul Lohmann GmbH, Emmertal, Germany);Other: Placebo tablet<br>* Placebo tablet will be administered on 4 days per week and will be identical in appearance to the iron tablet.<br>* Other names: Provided by Lomapharm (Paul Lohmann GmbH, Emmertal, Germany);Other: Placebo capsule<br>* Placebo capsules contain medium chain triglycerides and will be identical in appearance and total fat content to the DHA/EPA capsules.<br>* Other names: Will be provided by R.P. Scherer GmbH (Eberbach, Germany);|
| Experimental: iron tablet and placebo capsules<br> | Other: Placebo capsule<br>* Placebo capsules contain medium chain triglycerides and will be identical in appearance and total fat content to the DHA/EPA capsules.<br>* Other names: Will be provided by R.P. Scherer GmbH (Eberbach, Germany);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive and behavioral performance and immune function |  | 8 months | 

Secondary Outcome Measures

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