NCT02831712

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2013

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

3.7 years

First QC Date

July 11, 2016

Last Update Submit

July 15, 2016

Conditions

Effect of Iron Status on Occurrence of NTBI

Keywords

NTBIIron statusIron supplement

Outcome Measures

Primary Outcomes (1)

  • Concentration of NTBI after an oral iron load

    Blood samples collected 2 h after the iron supplement consumption will be measured for NTBI concentration

    2 hour post dose

Secondary Outcomes (1)

  • Dependence of NTBI concentration on markers of iron status (concentrations of serum iron, serum ferritin, transferrin saturation)

    2 hour post dose

Study Arms (1)

Iron supplement

OTHER

Ferrous Fumarate tablet 200 mg

Dietary Supplement: Ferrous Fumarate

Interventions

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.

Iron supplement

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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 \[serum ferritin concentration within normal range (15-200 ng/mL for females, 30-300 ng/mL for males) but low hemoglobin (\< 12 g/dL for females, \< 14 g/dL for males)\]

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University of Singapore; National University Hospital

Singapore, Singapore

Location

Related Publications (12)

  • 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.

    PMID: 21996204BACKGROUND

  • 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.

    PMID: 21382180BACKGROUND

  • 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.

    PMID: 21429441BACKGROUND

  • 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.

    PMID: 15979061BACKGROUND

  • 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.

    PMID: 21310008BACKGROUND

  • 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.

    PMID: 16941810BACKGROUND

  • 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.

    PMID: 11269606BACKGROUND

  • 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.

    PMID: 619599BACKGROUND

  • 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.

    PMID: 15629195BACKGROUND

  • 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.

    PMID: 15530152BACKGROUND

  • 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.

    PMID: 18304722BACKGROUND

  • 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.

    PMID: 22398912BACKGROUND

MeSH Terms

Interventions

ferrous fumarate

Study Officials

  • Thomas Walczyk, Ph.D

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 11, 2016

First Posted

July 13, 2016

Study Start

April 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 19, 2016

Record last verified: 2016-07

Locations

SG(1)