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

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ClinicalTrials.gov Identifier: NCT02831712
Recruitment Status : Unknown
Verified July 2016 by Thomas Walczyk, National University, Singapore.
Recruitment status was:  Active, not recruiting
First Posted : July 13, 2016
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):
Thomas Walczyk, National University, Singapore

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.

Condition or disease Intervention/treatment Phase
Effect of Iron Status on Occurrence of NTBI Dietary Supplement: Ferrous Fumarate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Effect of Iron Status on Occurrence of Non-transferrin-bound Iron (NTBI) in Serum in Response to an Oral Iron Load
Study Start Date : April 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Iron supplement
Ferrous Fumarate tablet 200 mg
Dietary Supplement: Ferrous Fumarate
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Dependence of NTBI concentration on markers of iron status (concentrations of serum iron, serum ferritin, transferrin saturation) [ Time Frame: 2 hour post dose ]
    Correlation between NTBI concentration and iron status indicators will be evaluated



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831712


Locations
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Singapore
National University of Singapore; National University Hospital
Singapore, Singapore
Sponsors and Collaborators
Thomas Walczyk
Investigators
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Principal Investigator: Thomas Walczyk, Ph.D National University, Singapore

Publications:

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Responsible Party: Thomas Walczyk, Associate Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT02831712    
Other Study ID Numbers: 13-093
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016
Keywords provided by Thomas Walczyk, National University, Singapore:
NTBI
Iron status
Iron supplement
Additional relevant MeSH terms:
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Iron
Ferrous fumarate
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs