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

Not Applicable

Completed

• Conditions: Iron Deficiency; Anemia
• Interventions: Dietary Supplement: DHA and EPA Fish Oil capsule; Dietary Supplement: Iron tablet; Other: Placebo tablet; Other: Placebo capsule

• Registration Number: NCT01092377
• Lead Sponsor: North-West University, South Africa

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 Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-23
• Study First Submitted QC: 2010-03-23
• Study First Posted: 2010-03-24
• Primary Completion: 2010-11
• Status Verified: 2010-12
• Study Completion: 2010-12
• Last Update Submitted: 2011-01-13
• Last Update Posted: 2011-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
DHA/EPA capsules and iron tablet	DHA and EPA Fish Oil capsule	-
DHA/EPA capsules and iron tablet	Iron tablet	-
DHA/EPA and placebo tablet	DHA and EPA Fish Oil capsule	-
DHA/EPA and placebo tablet	Placebo tablet	-
placebo capsules & placebo tablet	Iron tablet	-
placebo capsules & placebo tablet	Placebo tablet	-
placebo capsules & placebo tablet	Placebo capsule	-
iron tablet and placebo capsules	Placebo capsule	-

Primary Outcome Measures

Name	Time	Method
Change in cognitive and behavioral performance and immune function	8 months

Secondary Outcome Measures

Name	Time	Method
Change in activity levels, gut microbiota, iron status, fatty acid status and gene expression	8 months

Trial Locations

Locations (1)

Valley of a Thousand Hills; 🇿🇦 Botha's Hill, KwaZulu-Natal, South Africa