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

Thomas Walczyk50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Effect of Iron Status on Occurrence of NTBI

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

National University of Singapore; National University Hospital

Singapore, Singapore

Outcomes

Primary Outcomes

Concentration of NTBI after an oral iron load

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

Time frame: 2 hour post dose

Secondary Outcomes

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

Time frame: 2 hour post dose

Data from ClinicalTrials.gov

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