The Effects of Iron and Omega-3 Fatty Acid Supplementation on Cognition and Immune Function in Iron Deficient Children
NCT ID: NCT01092377
Last Updated: 2011-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
320 participants
INTERVENTIONAL
2010-02-28
2010-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Additionally, the effects on iron and fatty acid status, and gut microbiota, will be assessed.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Omega-3 Fatty Acids Supplement in Cognition of Young Healthy Adults and in Their Reaction Time of Computerized Test After 3 Months of Taking High-concentrated DHA and EPA Fish Softgels
NCT03781557
Nutrigenomics, PUFA, Iron and Cognition Amongst Under-two-year-old Indonesian Children
NCT01504633
The Effects of EPA/DHA Supplementation on Cognitive Control in Children With ADHD
NCT01554462
Effects of Docosahexaenoic and Eicosapentaenoic Acids in Hypercholesterolemic Children Plus Diet on Docosahexaenoic Acid (DHA) Status
NCT00678067
Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes
NCT01576783
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
BASIC_SCIENCE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DHA/EPA capsules and iron tablet
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
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.
DHA/EPA and placebo tablet
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
Placebo tablet
Placebo tablet will be administered on 4 days per week and will be identical in appearance to the iron tablet.
placebo capsules & placebo tablet
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.
Placebo tablet
Placebo tablet will be administered on 4 days per week and will be identical in appearance to the iron tablet.
Placebo capsule
Placebo capsules contain medium chain triglycerides and will be identical in appearance and total fat content to the DHA/EPA capsules.
iron tablet and placebo capsules
Placebo capsule
Placebo capsules contain medium chain triglycerides and will be identical in appearance and total fat content to the DHA/EPA capsules.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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.
Placebo tablet
Placebo tablet will be administered on 4 days per week and will be identical in appearance to the iron tablet.
Placebo capsule
Placebo capsules contain medium chain triglycerides and will be identical in appearance and total fat content to the DHA/EPA capsules.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Severe anemia (Hb \< 80 g/L)
* Use of iron or n-3 fatty acid containing supplements
6 Years
10 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Swiss Federal Institute of Technology
OTHER
Medical Research Council, South Africa
OTHER
Unilever R&D
INDUSTRY
North-West University, South Africa
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
North-West University, South Africa
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marius Smuts, PhD
Role: STUDY_DIRECTOR
North-West University
Michael B Zimmermann, PhD
Role: STUDY_DIRECTOR
ETH Zürich
Linda Malan, MSc
Role: PRINCIPAL_INVESTIGATOR
North-West University
Jeannine Baumgartner, MSc
Role: PRINCIPAL_INVESTIGATOR
ETH Zürich
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Valley of a Thousand Hills
Botha’s Hill, KwaZulu-Natal, South Africa
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FeFA study 2010
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.