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

NCT01092377 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2011-01-14

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Swiss Federal Institute of Technology

    collaborator OTHER
  • Medical Research Council, South Africa

    collaborator OTHER
  • Unilever R&D

    collaborator INDUSTRY
  • North-West University, South Africa

    lead OTHER

Principal Investigators

  • Marius Smuts, PhD · North-West University

  • Michael B Zimmermann, PhD · ETH Zürich

  • Linda Malan, MSc · North-West University

  • Jeannine Baumgartner, MSc · ETH Zürich

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
6 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-11-30
Completion
2010-12-31

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01092377 on ClinicalTrials.gov