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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- Change in cognitive and behavioral performance and immune function
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in cognitive and behavioral performance and immune function
Time Frame: 8 months
Secondary Outcomes
- Change in activity levels, gut microbiota, iron status, fatty acid status and gene expression(8 months)