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

North-West University, South Africa

Status: Completed

Conditions: Anemia; Iron Deficiency

Treatments: Dietary Supplement: DHA and EPA Fish Oil capsule; Other: Placebo tablet; Dietary Supplement: Iron tablet; Other: Placebo capsule

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01092377

FeFA study 2010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 patients

Sex: All

Ages: 6 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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320 participants in 4 patient groups, including a placebo group

DHA/EPA capsules and iron tablet

Experimental group

Treatment:

Dietary Supplement: Iron tablet

Dietary Supplement: DHA and EPA Fish Oil capsule

DHA/EPA and placebo tablet

Experimental group

Treatment:

Other: Placebo tablet

Dietary Supplement: DHA and EPA Fish Oil capsule

placebo capsules & placebo tablet

Placebo Comparator group

Treatment:

Other: Placebo capsule

Dietary Supplement: Iron tablet

Other: Placebo tablet

iron tablet and placebo capsules

Experimental group

Treatment:

Other: Placebo capsule