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

Anemia Clinical Trial

— FeFA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01092377
• Other study ID #: FeFA study 2010
• Status: Completed
• Phase: N/A
• First received: March 23, 2010
• Last updated: January 13, 2011
• Start date: February 2010
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: North-West University, South Africa
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Human Research Ethics CommitteeSwitzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 10 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

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

Locations

Country	Name	City	State
South Africa	Valley of a Thousand Hills	Botha's Hill	KwaZulu-Natal

Sponsors (4)

Lead Sponsor	Collaborator
North-West University, South Africa	Medical Research Council, South Africa, Swiss Federal Institute of Technology, Unilever R&D

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognitive and behavioral performance and immune function		8 months	No
Secondary	Change in activity levels, gut microbiota, iron status, fatty acid status and gene expression		8 months	Yes