NCT01092377

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 14, 2011

Status Verified

December 1, 2010

Enrollment Period

9 months

First QC Date

March 23, 2010

Last Update Submit

January 13, 2011

Conditions

Iron DeficiencyAnemia

Outcome Measures

Primary Outcomes (1)

  • Change in cognitive and behavioral performance and immune function

    8 months

Secondary Outcomes (1)

  • Change in activity levels, gut microbiota, iron status, fatty acid status and gene expression

    8 months

Study Arms (4)

DHA/EPA capsules and iron tablet

EXPERIMENTAL
Dietary Supplement: DHA and EPA Fish Oil capsuleDietary Supplement: Iron tablet

DHA/EPA and placebo tablet

EXPERIMENTAL
Dietary Supplement: DHA and EPA Fish Oil capsuleOther: Placebo tablet

placebo capsules & placebo tablet

PLACEBO COMPARATOR
Dietary Supplement: Iron tabletOther: Placebo tabletOther: Placebo capsule

iron tablet and placebo capsules

EXPERIMENTAL
Other: Placebo capsule

Interventions

DHA and EPA Fish Oil capsuleDIETARY_SUPPLEMENT

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

Also known as: Provided by Burgerstein AG (Rapperswil, Switzerland)
DHA/EPA and placebo tabletDHA/EPA capsules and iron tablet
Iron tabletDIETARY_SUPPLEMENT

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.

Also known as: Provided by Lomapharm (Paul Lohmann GmbH, Emmertal, Germany)
DHA/EPA capsules and iron tabletplacebo capsules & placebo tablet
Placebo tabletOTHER

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

Also known as: Provided by Lomapharm (Paul Lohmann GmbH, Emmertal, Germany)
DHA/EPA and placebo tabletplacebo capsules & placebo tablet
Placebo capsuleOTHER

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

Also known as: Will be provided by R.P. Scherer GmbH (Eberbach, Germany)
iron tablet and placebo capsulesplacebo capsules & placebo tablet

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Chronic illness
  • Severe anemia (Hb \< 80 g/L)
  • Use of iron or n-3 fatty acid containing supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Valley of a Thousand Hills

Botha’s Hill, KwaZulu-Natal, South Africa

Location

Related Publications (5)

  • Malan L, Baumgartner J, Calder PC, Smuts CM. Low immune cell ARA and high plasma 12-HETE and 17-HDHA in iron-deficient South African school children with allergy. Prostaglandins Leukot Essent Fatty Acids. 2016 Jul;110:35-41. doi: 10.1016/j.plefa.2016.05.006. Epub 2016 May 13.

    PMID: 27255641DERIVED

  • Malan L, Baumgartner J, Zandberg L, Calder PC, Smuts CM. Iron and a mixture of DHA and EPA supplementation, alone and in combination, affect bioactive lipid signalling and morbidity of iron deficient South African school children in a two-by-two randomised controlled trial. Prostaglandins Leukot Essent Fatty Acids. 2016 Feb;105:15-25. doi: 10.1016/j.plefa.2015.12.005. Epub 2015 Dec 22.

    PMID: 26869087DERIVED

  • Malan L, Baumgartner J, Calder PC, Zimmermann MB, Smuts CM. n-3 Long-chain PUFAs reduce respiratory morbidity caused by iron supplementation in iron-deficient South African schoolchildren: a randomized, double-blind, placebo-controlled intervention. Am J Clin Nutr. 2015 Mar;101(3):668-79. doi: 10.3945/ajcn.113.081208. Epub 2014 Dec 31.

    PMID: 25733652DERIVED

  • Baumgartner J, Smuts CM, Malan L, Kvalsvig J, van Stuijvenberg ME, Hurrell RF, Zimmermann MB. Effects of iron and n-3 fatty acid supplementation, alone and in combination, on cognition in school children: a randomized, double-blind, placebo-controlled intervention in South Africa. Am J Clin Nutr. 2012 Dec;96(6):1327-38. doi: 10.3945/ajcn.112.041004. Epub 2012 Oct 24.

    PMID: 23097272DERIVED

  • Baumgartner J, Smuts CM, Aeberli I, Malan L, Tjalsma H, Zimmermann MB. Overweight impairs efficacy of iron supplementation in iron-deficient South African children: a randomized controlled intervention. Int J Obes (Lond). 2013 Jan;37(1):24-30. doi: 10.1038/ijo.2012.145. Epub 2012 Sep 4.

    PMID: 22945607DERIVED

MeSH Terms

Conditions

Iron DeficienciesAnemia

Interventions

Iron

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Marius Smuts, PhD

    North-West University

    STUDY DIRECTOR

  • Michael B Zimmermann, PhD

    ETH Zürich

    STUDY DIRECTOR

  • Linda Malan, MSc

    North-West University

    PRINCIPAL INVESTIGATOR

  • Jeannine Baumgartner, MSc

    ETH Zürich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2010

First Posted

March 24, 2010

Study Start

February 1, 2010

Primary Completion

November 1, 2010

Study Completion

December 1, 2010

Last Updated

January 14, 2011

Record last verified: 2010-12

Locations

ZA(1)