Anemia, Iron Deficiency
Conditions
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.
Interventions
DIETARY_SUPPLEMENTDHA 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_SUPPLEMENTIron 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.
OTHERPlacebo tablet
Placebo tablet will be administered on 4 days per week and will be identical in appearance to the iron tablet.
OTHERPlacebo capsule
Placebo capsules contain medium chain triglycerides and will be identical in appearance and total fat content to the DHA/EPA capsules.
Sponsors
Swiss Federal Institute of Technology
Medical Research Council, South Africa
Unilever R&D
North-West University, South Africa
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 10 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cognitive and behavioral performance and immune function | 8 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in activity levels, gut microbiota, iron status, fatty acid status and gene expression | 8 months |
Countries
South Africa
Outcome results
None listed