Effect of Iron Status on Occurrence of NTBINCT02831712

Effect of Iron Status on Occurrence of Non-transferrin-bound Iron (NTBI) in Serum in Response to an Oral Iron Load

A study testing Ferrous Fumarate in people with Effect of Iron Status on Occurrence of NTBI, run by Thomas Walczyk at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

This study aims to investigate a possible effect of iron status on temporary build-up of non-transferrin bound iron (NTBI) in healthy volunteers upon iron supplementation. Read more about this study

Who is it for?: Ages 21 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Effect of Iron Status on Occurrence of NTBI
What is being tested?: Ferrous Fumarate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteSingapore
Study dates: Apr 2013to Dec 2016
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 21 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Apparently healthy volunteers (21 - 55 years old)
C-reactive protein (CRP) < 5

Who cannot join

Blood donation or significant blood loss (e.g. surgery) within the past 4 months
Regular intake of iron and other nutrient supplements within the past 4 months
Regular intake of medication except oral contraceptives
Acute or recent inflammatory or infectious symptoms
Chronic gastrointestinal disorders or metabolic diseases
Pregnancy or lactation

Show all 9Show fewer

Coeliac disease or gluten-related disorders
Iron overload conditions (serum ferritin concentration > 200 ng/mL for females, > 300 ng/mL for males)
Non iron deficiency anemia [serum ferritin concentration within normal range (15-200 ng/mL for females, 30-300 ng/mL for males) but low hemoglobin (< 12 g/dL for females, < 14 g/dL for males)]

Trial locations and contacts

1 site in 1 country.

Singapore1 site

National University of Singapore; National University Hospital
Singapore

Other trials in Singapore

About this study

This study aims to investigate a possible effect of iron status on temporary build-up of non-transferrin bound iron (NTBI) in healthy volunteers upon iron supplementation.

Read the detailed description

For Visit 1, blood samples will be collected to assess iron status. For Visit 2, after an overnight fast, iron supplement will be provided to participant before breakfast. Blood samples will be collected right before and 2 h after iron supplement consumption for NTBI analysis.

NTBI concentration before and after iron supplement consumption will be compared. Dependence of NTBI formation on markers of iron status (serum iron, transferrin, transferrin saturation, serum ferritin and hemoglobin) will be evaluated.

Conditions: Effect of Iron Status on Occurrence of NTBI
Being tested: Ferrous Fumarate
Keywords: NTBI, Iron status, Iron supplement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ferrous FumarateDietary supplement
One tablet of a commercial iron supplement (Ferrous Fumarate 200 mg, from Drug House of Australia) will be provided to participants after overnight fast. The intervention is only one time.

Study groups in NCT02831712
Study group	Role	What they receive
Iron supplement	Other	Ferrous Fumarate tablet 200 mg Receives: Dietary Supplement: Ferrous Fumarate

What is being measured

The primary outcome is the main question the study is designed to answer.

Concentration of NTBI after an oral iron load
Blood samples collected 2 h after the iron supplement consumption will be measured for NTBI concentration
Measured: 2 hour post dose

Secondary outcomes (1)

Dependence of NTBI concentration on markers of iron status (concentrations of serum iron, serum ferritin, transferrin saturation)
Correlation between NTBI concentration and iron status indicators will be evaluated
Measured: 2 hour post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013Dec 2016

First posted13 Jul 2016 (estimated)
Study startApr 2013
Primary completionDec 2016 (estimated)
Study completionDec 2016 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Effect of Iron Status on Occurrence of NTBIStudies 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: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02831712
Sponsor's protocol ID: 13-093
Status last verified: Jul 2016
First submitted: 11 Jul 2016
Last updated: 19 Jul 2016
Results posted: No
Data monitoring committee: No

Publications

Malyszko J, Glowinska I, Malyszko JS, Levin-Iaina N, Koc-Zorawska E, Mysliwiec M. Iron metabolism in kidney allograft recipients: still a mystery? Transplant Proc. 2011 Oct;43(8):2973-5. doi: 10.1016/j.transproceed.2011.08.055.
PubMed 21996204
Inati A, Musallam KM, Cappellini MD, Duca L, Taher AT. Nontransferrin-bound iron in transfused patients with sickle cell disease. Int J Lab Hematol. 2011 Apr;33(2):133-7. doi: 10.1111/j.1751-553X.2010.01224.x.
PubMed 21382180
Ounjaijean S, Westermarck T, Partinen M, Plonka-Poltorak E, Kaipainen P, Kaski M, Fucharoen S, Srichairatanakool S, Atroshi F. Increase in non-transferrin bound iron and the oxidative stress status in epilepsy patients treated using valproic acid monotherapy. Int J Clin Pharmacol Ther. 2011 Apr;49(4):268-76. doi: 10.5414/CP201466.
PubMed 21429441
Prakash M, Upadhya S, Prabhu R. Serum non-transferrin bound iron in hemodialysis patients not receiving intravenous iron. Clin Chim Acta. 2005 Oct;360(1-2):194-8. doi: 10.1016/j.cccn.2005.04.024.
PubMed 15979061
Yegin ZA, Pasaoglu H, Aki SZ, Ozkurt ZN, Demirtas C, Yagci M, Acar K, Sucak GT. Pro-oxidative/antioxidative imbalance: a key indicator of adverse outcome in hematopoietic stem cell transplantation. Int J Lab Hematol. 2011 Aug;33(4):414-23. doi: 10.1111/j.1751-553X.2011.01297.x. Epub 2011 Feb 10.
PubMed 21310008
Duca L, Da Ponte A, Cozzi M, Carbone A, Pomati M, Nava I, Cappellini MD, Fiorelli G. Changes in erythropoiesis, iron metabolism and oxidative stress after half-marathon. Intern Emerg Med. 2006;1(1):30-4. doi: 10.1007/BF02934717.
PubMed 16941810
Trumbo P, Yates AA, Schlicker S, Poos M. Dietary reference intakes: vitamin A, vitamin K, arsenic, boron, chromium, copper, iodine, iron, manganese, molybdenum, nickel, silicon, vanadium, and zinc. J Am Diet Assoc. 2001 Mar;101(3):294-301. doi: 10.1016/S0002-8223(01)00078-5. No abstract available.
PubMed 11269606
Monsen ER, Hallberg L, Layrisse M, Hegsted DM, Cook JD, Mertz W, Finch CA. Estimation of available dietary iron. Am J Clin Nutr. 1978 Jan;31(1):134-41. doi: 10.1093/ajcn/31.1.134.
PubMed 619599
Papanikolaou G, Pantopoulos K. Iron metabolism and toxicity. Toxicol Appl Pharmacol. 2005 Jan 15;202(2):199-211. doi: 10.1016/j.taap.2004.06.021.
PubMed 15629195
Hutchinson C, Al-Ashgar W, Liu DY, Hider RC, Powell JJ, Geissler CA. Oral ferrous sulphate leads to a marked increase in pro-oxidant nontransferrin-bound iron. Eur J Clin Invest. 2004 Nov;34(11):782-4. doi: 10.1111/j.1365-2362.2004.01416.x. No abstract available.
PubMed 15530152
Baron J, Ben-David G, Hallak M. Changes in non-transferrin-bound iron (NTBI) in pregnant women on iron supplements. Eur J Obstet Gynecol Reprod Biol. 2008 Oct;140(2):281-2. doi: 10.1016/j.ejogrb.2008.01.002. Epub 2008 Mar 4. No abstract available.
PubMed 18304722
Schumann K, Kroll S, Romero-Abal ME, Georgiou NA, Marx JJ, Weiss G, Solomons NW. Impact of oral iron challenges on circulating non-transferrin-bound iron in healthy Guatemalan males. Ann Nutr Metab. 2012;60(2):98-107. doi: 10.1159/000336177. Epub 2012 Mar 6.
PubMed 22398912

Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Iron Status on Occurrence of Non-transferrin-bound Iron (NTBI) in Serum in Response to an Oral Iron Load
ClinicalTrials.gov ID: NCT02831712
Acronym / sponsor ID: 13-093
Conditions: Effect of Iron Status on Occurrence of NTBI
Keywords: NTBI, Iron status, Iron supplement
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 50 participants (estimated)
Lead sponsor: Thomas WalczykUniversity, hospital or other
Study start: Apr 2013
Primary completion: Dec 2016 (estimated)
Study completion: Dec 2016 (estimated)
First posted: 13 Jul 2016 (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.

This study aims to investigate a possible effect of iron status on temporary build-up of non-transferrin bound iron (NTBI) in healthy volunteers upon iron supplementation.

Detailed description

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Iron supplement	Other	Dietary Supplement: Ferrous FumarateFerrous Fumarate tablet 200 mg

Who may qualify

Ages: 21 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Apparently healthy volunteers (21 - 55 years old)
C-reactive protein (CRP) < 5

Key exclusion criteria (9 listed)

Blood donation or significant blood loss (e.g. surgery) within the past 4 months
Regular intake of iron and other nutrient supplements within the past 4 months
Regular intake of medication except oral contraceptives
Acute or recent inflammatory or infectious symptoms
Chronic gastrointestinal disorders or metabolic diseases

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
Ferrous FumarateOne tablet of a commercial iron supplement (Ferrous Fumarate 200 mg, from Drug House of Australia) will be provided to participants after overnight fast. The intervention is only one time.	Dietary supplement	Iron supplement

Primary outcome

Concentration of NTBI after an oral iron load
Time frame: 2 hour post dose
Blood samples collected 2 h after the iron supplement consumption will be measured for NTBI concentration

1 secondary outcome

Dependence of NTBI concentration on markers of iron status (concentrations of serum iron, serum ferritin, transferrin saturation)
Time frame: 2 hour post dose

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
Background: PubMed 21996204Malyszko J, Glowinska I, Malyszko JS, Levin-Iaina N, Koc-Zorawska E, Mysliwiec M. Iron metabolism in kidney allograft recipients: still a mystery? Transplant Proc. 2011 Oct;43(8):2973-5. doi: 10.1016/j.transproceed.2011.08.055.
Background: PubMed 21382180Inati A, Musallam KM, Cappellini MD, Duca L, Taher AT. Nontransferrin-bound iron in transfused patients with sickle cell disease. Int J Lab Hematol. 2011 Apr;33(2):133-7. doi: 10.1111/j.1751-553X.2010.01224.x.
Background: PubMed 21429441Ounjaijean S, Westermarck T, Partinen M, Plonka-Poltorak E, Kaipainen P, Kaski M, Fucharoen S, Srichairatanakool S, Atroshi F. Increase in non-transferrin bound iron and the oxidative stress status in epilepsy patients treated using valproic acid monotherapy. Int J Clin Pharmacol Ther. 2011 Apr;49(4):268-76. doi: 10.5414/CP201466.
Background: PubMed 15979061Prakash M, Upadhya S, Prabhu R. Serum non-transferrin bound iron in hemodialysis patients not receiving intravenous iron. Clin Chim Acta. 2005 Oct;360(1-2):194-8. doi: 10.1016/j.cccn.2005.04.024.
Background: PubMed 21310008Yegin ZA, Pasaoglu H, Aki SZ, Ozkurt ZN, Demirtas C, Yagci M, Acar K, Sucak GT. Pro-oxidative/antioxidative imbalance: a key indicator of adverse outcome in hematopoietic stem cell transplantation. Int J Lab Hematol. 2011 Aug;33(4):414-23. doi: 10.1111/j.1751-553X.2011.01297.x. Epub 2011 Feb 10.
Background: PubMed 16941810Duca L, Da Ponte A, Cozzi M, Carbone A, Pomati M, Nava I, Cappellini MD, Fiorelli G. Changes in erythropoiesis, iron metabolism and oxidative stress after half-marathon. Intern Emerg Med. 2006;1(1):30-4. doi: 10.1007/BF02934717.
Background: PubMed 11269606Trumbo P, Yates AA, Schlicker S, Poos M. Dietary reference intakes: vitamin A, vitamin K, arsenic, boron, chromium, copper, iodine, iron, manganese, molybdenum, nickel, silicon, vanadium, and zinc. J Am Diet Assoc. 2001 Mar;101(3):294-301. doi: 10.1016/S0002-8223(01)00078-5. No abstract available.
Background: PubMed 619599Monsen ER, Hallberg L, Layrisse M, Hegsted DM, Cook JD, Mertz W, Finch CA. Estimation of available dietary iron. Am J Clin Nutr. 1978 Jan;31(1):134-41. doi: 10.1093/ajcn/31.1.134.
Background: PubMed 15629195Papanikolaou G, Pantopoulos K. Iron metabolism and toxicity. Toxicol Appl Pharmacol. 2005 Jan 15;202(2):199-211. doi: 10.1016/j.taap.2004.06.021.
Background: PubMed 15530152Hutchinson C, Al-Ashgar W, Liu DY, Hider RC, Powell JJ, Geissler CA. Oral ferrous sulphate leads to a marked increase in pro-oxidant nontransferrin-bound iron. Eur J Clin Invest. 2004 Nov;34(11):782-4. doi: 10.1111/j.1365-2362.2004.01416.x. No abstract available.
Background: PubMed 18304722Baron J, Ben-David G, Hallak M. Changes in non-transferrin-bound iron (NTBI) in pregnant women on iron supplements. Eur J Obstet Gynecol Reprod Biol. 2008 Oct;140(2):281-2. doi: 10.1016/j.ejogrb.2008.01.002. Epub 2008 Mar 4. No abstract available.
Background: PubMed 22398912Schumann K, Kroll S, Romero-Abal ME, Georgiou NA, Marx JJ, Weiss G, Solomons NW. Impact of oral iron challenges on circulating non-transferrin-bound iron in healthy Guatemalan males. Ann Nutr Metab. 2012;60(2):98-107. doi: 10.1159/000336177. Epub 2012 Mar 6.

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.

Thomas Walczyk, Ph.D principal investigator

National University of Singapore

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ferrous Fumarate in people with Effect of Iron Status on Occurrence of NTBI, run by Thomas Walczyk at 1 site in Singapore.

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 9 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: status not confirmed, as of the sponsor's last update on 19 Jul 2016. 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 Singapore. 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. 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?

Results are not available in the source record.

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?

Concentration of NTBI after an oral iron load (time frame: 2 hour post dose). 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 NCT02831712, which also lists 12 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 19 Jul 2016.