The Effects of Iron and Omega-3 Fatty Acid Supplementation on Cognition and Immune Function in Iron Deficient Children
NCT01092377 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320
Last updated 2011-01-14
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.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
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
- DIETARY_SUPPLEMENT
-
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.
- OTHER
-
Placebo tablet
Placebo tablet will be administered on 4 days per week and will be identical in appearance to the iron tablet.
- OTHER
-
Placebo capsule
Placebo capsules contain medium chain triglycerides and will be identical in appearance and total fat content to the DHA/EPA capsules.
Sponsors & Collaborators
-
Swiss Federal Institute of Technology
collaborator OTHER -
Medical Research Council, South Africa
collaborator OTHER -
Unilever R&D
collaborator INDUSTRY -
North-West University, South Africa
lead OTHER
Principal Investigators
-
Marius Smuts, PhD · North-West University
-
Michael B Zimmermann, PhD · ETH Zürich
-
Linda Malan, MSc · North-West University
-
Jeannine Baumgartner, MSc · ETH Zürich
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- QUADRUPLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 6 Years
- Max Age
- 10 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-02-28
- Primary Completion
- 2010-11-30
- Completion
- 2010-12-31
Countries
- South Africa
Study Locations
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