Effect of Iron Status on Occurrence of NTBI
Conditions
Keywords
NTBI, Iron status, Iron supplement
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.
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.
Interventions
DIETARY_SUPPLEMENTFerrous 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.
Sponsors
Thomas Walczyk
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
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 \[serum ferritin concentration within normal range (15-200 ng/mL for females, 30-300 ng/mL for males) but low hemoglobin (\< 12 g/dL for females, \< 14 g/dL for males)\]
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of NTBI after an oral iron load | 2 hour post dose | Blood samples collected 2 h after the iron supplement consumption will be measured for NTBI concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dependence of NTBI concentration on markers of iron status (concentrations of serum iron, serum ferritin, transferrin saturation) | 2 hour post dose | Correlation between NTBI concentration and iron status indicators will be evaluated |
Countries
Singapore
Outcome results
None listed