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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Effect of Iron Status on Occurrence of NTBI

Intervention / Treatment
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* Dietary Supplement: Ferrous Fumarate


Participation Criteria
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Eligibility Criteria
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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)]

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Iron supplement<br>Ferrous Fumarate tablet 200 mg | Dietary Supplement: Ferrous Fumarate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 hour post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NTBI, Iron status, Iron supplement