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| Name | Class |
|---|---|
| Swiss Federal Institute of Technology | OTHER |
| Medical Research Council, South Africa | OTHER |
| Unilever R&D | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DHA/EPA capsules and iron tablet | Experimental |
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| DHA/EPA and placebo tablet | Experimental |
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| placebo capsules & placebo tablet | Placebo Comparator |
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| iron tablet and placebo capsules | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive and behavioral performance and immune function | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in activity levels, gut microbiota, iron status, fatty acid status and gene expression | 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marius Smuts, PhD | North-West University | Study Director |
| Michael B Zimmermann, PhD | ETH Zürich | Study Director |
| Linda Malan, MSc | North-West University | Principal Investigator |
| Jeannine Baumgartner, MSc | ETH Zürich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley of a Thousand Hills | Botha’s Hill | KwaZulu-Natal | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27255641 | Derived | Malan L, Baumgartner J, Calder PC, Smuts CM. Low immune cell ARA and high plasma 12-HETE and 17-HDHA in iron-deficient South African school children with allergy. Prostaglandins Leukot Essent Fatty Acids. 2016 Jul;110:35-41. doi: 10.1016/j.plefa.2016.05.006. Epub 2016 May 13. | |
| 26869087 | Derived | Malan L, Baumgartner J, Zandberg L, Calder PC, Smuts CM. Iron and a mixture of DHA and EPA supplementation, alone and in combination, affect bioactive lipid signalling and morbidity of iron deficient South African school children in a two-by-two randomised controlled trial. Prostaglandins Leukot Essent Fatty Acids. 2016 Feb;105:15-25. doi: 10.1016/j.plefa.2015.12.005. Epub 2015 Dec 22. |
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| 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. |
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| Placebo tablet | Other | Placebo tablet will be administered on 4 days per week and will be identical in appearance to the iron tablet. |
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| Placebo capsule | Other | Placebo capsules contain medium chain triglycerides and will be identical in appearance and total fat content to the DHA/EPA capsules. |
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| 25733652 | Derived | Malan L, Baumgartner J, Calder PC, Zimmermann MB, Smuts CM. n-3 Long-chain PUFAs reduce respiratory morbidity caused by iron supplementation in iron-deficient South African schoolchildren: a randomized, double-blind, placebo-controlled intervention. Am J Clin Nutr. 2015 Mar;101(3):668-79. doi: 10.3945/ajcn.113.081208. Epub 2014 Dec 31. |
| 23097272 | Derived | Baumgartner J, Smuts CM, Malan L, Kvalsvig J, van Stuijvenberg ME, Hurrell RF, Zimmermann MB. Effects of iron and n-3 fatty acid supplementation, alone and in combination, on cognition in school children: a randomized, double-blind, placebo-controlled intervention in South Africa. Am J Clin Nutr. 2012 Dec;96(6):1327-38. doi: 10.3945/ajcn.112.041004. Epub 2012 Oct 24. |
| 22945607 | Derived | Baumgartner J, Smuts CM, Aeberli I, Malan L, Tjalsma H, Zimmermann MB. Overweight impairs efficacy of iron supplementation in iron-deficient South African children: a randomized controlled intervention. Int J Obes (Lond). 2013 Jan;37(1):24-30. doi: 10.1038/ijo.2012.145. Epub 2012 Sep 4. |
| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D007501 | Iron |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
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