NCT01092377

The Effects of Iron and Omega-3 Fatty Acid Supplementation on Cognition and Immune Function in Iron Deficient Children

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: North-West University, South Africa · Academic / Other
• Sex: All
• Age: 6 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Iron Deficiency
• Anemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-11-01
• Completion: 2010-12-01
• First posted: 2010-03-24
• Last updated: 2011-01-14

Locations

1 site across 1 country: South Africa