Clinical trial NCT01092377: The Effects of Iron and Omega-3 Fatty Acid Supplementation on Cognition and Immune Function in Iron Deficient Children
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency
Anemia
Lead sponsor: North-West University, South Africa
Sponsor class: OTHER
Collaborators: name: Swiss Federal Institute of Technology
name: Medical Research Council, South Africa
name: Unilever R&D
First posted: 2010-03-24
Enrollment: 320
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in cognitive and behavioral performance and immune function
timeFrame: 8 months
Secondary outcomes:
measure: Change in activity levels, gut microbiota, iron status, fatty acid status and gene expression
timeFrame: 8 months
Other outcomes:
Locations:
city: Botha's Hill
country: South Africa
facility: Valley of a Thousand Hills
state: KwaZulu-Natal
Study officials:
affiliation: North-West University
name: Marius Smuts, PhD
role: STUDY_DIRECTOR
affiliation: ETH Zürich
name: Michael B Zimmermann, PhD
role: STUDY_DIRECTOR
affiliation: North-West University
name: Linda Malan, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: ETH Zürich
name: Jeannine Baumgartner, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.