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

This study has been completed.
Sponsor:
Collaborators:
Swiss Federal Institute of Technology
Medical Research Council, South Africa
Unilever R&D
Information provided by:
North-West University, South Africa
ClinicalTrials.gov Identifier:
NCT01092377
First received: March 23, 2010
Last updated: January 13, 2011
Last verified: December 2010
  Purpose

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.


Condition Intervention
Iron Deficiency
Anemia
Dietary Supplement: DHA and EPA Fish Oil capsule
Dietary Supplement: Iron tablet
Other: Placebo tablet
Other: Placebo capsule

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

Resource links provided by NLM:


Further study details as provided by North-West University, South Africa:

Primary Outcome Measures:
  • Change in cognitive and behavioral performance and immune function [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in activity levels, gut microbiota, iron status, fatty acid status and gene expression [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]

Enrollment: 320
Study Start Date: February 2010
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DHA/EPA capsules and iron tablet 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 Name: 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 Name: Provided by Lomapharm (Paul Lohmann GmbH, Emmertal, Germany)
Experimental: DHA/EPA and placebo tablet 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 Name: Provided by Burgerstein AG (Rapperswil, Switzerland)
Other: Placebo tablet
Placebo tablet will be administered on 4 days per week and will be identical in appearance to the iron tablet.
Other Name: Provided by Lomapharm (Paul Lohmann GmbH, Emmertal, Germany)
Placebo Comparator: placebo capsules & placebo tablet 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 Name: 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 Name: 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 Name: Will be provided by R.P. Scherer GmbH (Eberbach, Germany)
Experimental: iron tablet and placebo capsules 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 Name: Will be provided by R.P. Scherer GmbH (Eberbach, Germany)

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.

  Eligibility

Ages Eligible for Study:   6 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092377

Locations
South Africa
Valley of a Thousand Hills
Botha's Hill, KwaZulu-Natal, South Africa
Sponsors and Collaborators
North-West University, South Africa
Swiss Federal Institute of Technology
Medical Research Council, South Africa
Unilever R&D
Investigators
Study Director: Marius Smuts, PhD North-West University
Study Director: Michael B Zimmermann, PhD ETH Zürich
Principal Investigator: Linda Malan, MSc North-West University
Principal Investigator: Jeannine Baumgartner, MSc ETH Zürich
  More Information

No publications provided by North-West University, South Africa

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Marius Smuts, North-West University, South Africa
ClinicalTrials.gov Identifier: NCT01092377     History of Changes
Other Study ID Numbers: FeFA study 2010
Study First Received: March 23, 2010
Last Updated: January 13, 2011
Health Authority: South Africa: Human Research Ethics Committee
Switzerland: Ethikkommission

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014