Iron DeficiencyFeFANCT01092377
The Effects of Iron and Omega-3 Fatty Acid Supplementation on Cognition and Immune Function in Iron Deficient Children
A study testing DHA and EPA Fish Oil capsule and Iron tablet in people with Iron Deficiency and Anemia, run by North-West University, South Africa at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Iron Deficiency, Anemia
- What is being tested?
- DHA and EPA Fish Oil capsule and Iron tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteSouth Africa
- Study dates
- Feb 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Chronic illness
- Severe anemia (Hb < 80 g/L)
- Use of iron or n-3 fatty acid containing supplements
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Valley of a Thousand Hills
Botha’s Hill, KwaZulu-Natal
About this study
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
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.
Read the 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.
- Conditions
- Iron Deficiency, Anemia
- Being tested
- DHA and EPA Fish Oil capsule, Iron tablet, Placebo tablet, Placebo capsule
- Medical subject headings
- Iron Deficiencies, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA and EPA Fish Oil capsuleDietary supplement
Also called Provided by Burgerstein AG (Rapperswil, Switzerland)
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 tabletDietary supplement
Also called Provided by Lomapharm (Paul Lohmann GmbH, Emmertal, Germany)
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.
Placebo tabletOther
Also called Provided by Lomapharm (Paul Lohmann GmbH, Emmertal, Germany)
Placebo tablet will be administered on 4 days per week and will be identical in appearance to the iron tablet.
Placebo capsuleOther
Also called Will be provided by R.P. Scherer GmbH (Eberbach, Germany)
Placebo capsules contain medium chain triglycerides and will be identical in appearance and total fat content to the DHA/EPA capsules.
| Study group | Role | What they receive |
|---|---|---|
| DHA/EPA capsules and iron tablet | Experimental | Not described Receives: Dietary Supplement: DHA and EPA Fish Oil capsule; Dietary Supplement: Iron tablet |
| DHA/EPA and placebo tablet | Experimental | Not described Receives: Dietary Supplement: DHA and EPA Fish Oil capsule; Other: Placebo tablet |
| placebo capsules & placebo tablet | Placebo comparator | Not described Receives: Dietary Supplement: Iron tablet; Other: Placebo tablet; Other: Placebo capsule |
| iron tablet and placebo capsules | Experimental | Not described Receives: Other: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive and behavioral performance and immune function
Measured: 8 months
Secondary outcomes (1)
Change in activity levels, gut microbiota, iron status, fatty acid status and gene expression
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- North-West University, South Africa
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Federal Institute of Technology, Medical Research Council, South Africa, Unilever R&D
- Investigators
- Marius Smuts, PhD, Study director, North-West UniversityMichael B Zimmermann, PhD, Study director, ETH ZürichLinda Malan, MSc, Principal investigator, North-West UniversityJeannine Baumgartner, MSc, Principal investigator, ETH Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092377
- Sponsor's protocol ID
- FeFA study 2010
- Acronym
- FeFA
- Status last verified
- Dec 2010
- First submitted
- 23 Mar 2010
- Last updated
- 14 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27255641Malan 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.
PubMed 26869087Malan 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.
PubMed 25733652Baumgartner 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.
PubMed 23097272Baumgartner 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.
PubMed 22945607
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01092377
- Acronym / sponsor ID
- FeFA / FeFA study 2010
- Conditions
- Iron Deficiency, Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- North-West University, South AfricaUniversity, hospital or other
- Collaborators
- Swiss Federal Institute of Technology, Medical Research Council, South Africa, Unilever R&D
- Study start
- Feb 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 24 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DHA/EPA capsules and iron tablet | Experimental | Dietary Supplement: DHA and EPA Fish Oil capsule, Dietary Supplement: Iron tablet |
| DHA/EPA and placebo tablet | Experimental | Dietary Supplement: DHA and EPA Fish Oil capsule, Other: Placebo tablet |
| placebo capsules & placebo tablet | Placebo comparator | Dietary Supplement: Iron tablet, Other: Placebo tablet, Other: Placebo capsule |
| iron tablet and placebo capsules | Experimental | Other: Placebo capsule |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Chronic illness
- Severe anemia (Hb < 80 g/L)
- Use of iron or n-3 fatty acid containing supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHA and EPA Fish Oil capsuleAlso: Provided by Burgerstein AG (Rapperswil, Switzerland)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 | DHA/EPA and placebo tablet, DHA/EPA capsules and iron tablet |
| Iron tabletAlso: Provided by Lomapharm (Paul Lohmann GmbH, Emmertal, Germany)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. | Dietary supplement | DHA/EPA capsules and iron tablet, placebo capsules & placebo tablet |
| Placebo tabletAlso: Provided by Lomapharm (Paul Lohmann GmbH, Emmertal, Germany)Placebo tablet will be administered on 4 days per week and will be identical in appearance to the iron tablet. | Other | DHA/EPA and placebo tablet, placebo capsules & placebo tablet |
| Placebo capsuleAlso: Will be provided by R.P. Scherer GmbH (Eberbach, Germany)Placebo capsules contain medium chain triglycerides and will be identical in appearance and total fat content to the DHA/EPA capsules. | Other | iron tablet and placebo capsules, placebo capsules & placebo tablet |
Primary outcome
Change in cognitive and behavioral performance and immune function
Time frame: 8 months
1 secondary outcome
Change in activity levels, gut microbiota, iron status, fatty acid status and gene expression
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2011.
- Derived from this study: PubMed 27255641Malan 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.
- Derived from this study: PubMed 26869087Malan 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.
- Derived from this study: PubMed 25733652Malan 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.
- Derived from this study: PubMed 23097272Baumgartner 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.
- Derived from this study: PubMed 22945607Baumgartner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marius Smuts, PhD study director
North-West University
Michael B Zimmermann, PhD study director
ETH Zürich
Linda Malan, MSc principal investigator
North-West University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DHA and EPA Fish Oil capsule and Iron tablet in people with Iron Deficiency and Anemia, run by North-West University, South Africa at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive and behavioral performance and immune function (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01092377, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2011.