Trial | NCT01092377  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    320
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.
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 Started
Feb 28
2010
Primary Completion
Nov 30
2010
Study Completion
Dec 31
2010
Last Update
Jan 14
2011
Estimate

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

  • Other names: Provided by Burgerstein AG (Rapperswil, Switzerland)

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 names: Provided by Lomapharm (Paul Lohmann GmbH, Emmertal, Germany)

Other Placebo tablet

Placebo tablet will be administered on 4 days per week and will be identical in appearance to the iron tablet.

  • Other names: Provided by Lomapharm (Paul Lohmann GmbH, Emmertal, Germany)

Other Placebo capsule

Placebo capsules contain medium chain triglycerides and will be identical in appearance and total fat content to the DHA/EPA capsules.

  • Other names: Will be provided by R.P. Scherer GmbH (Eberbach, Germany)

DHA/EPA capsules and iron tablet Experimental

DHA/EPA and placebo tablet Experimental

placebo capsules & placebo tablet Placebo Comparator

iron tablet and placebo capsules Experimental

Criteria 

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
No Results Posted