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.
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
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
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Thomas Walczyk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Walczyk, National University of Singapore
- Investigators
- Thomas Walczyk, Ph.D, Principal investigator, National University of Singapore
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 21996204Inati 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 21382180Ounjaijean 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 21429441Prakash 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 15979061Yegin 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 21310008Duca 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 16941810Trumbo 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 11269606Monsen 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 619599Papanikolaou 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 15629195Hutchinson 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 15530152Baron 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 18304722Schumann 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