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

Thomas Walczyk

Status

Unknown

Conditions

Effect of Iron Status on Occurrence of NTBI

Treatments

Dietary Supplement: Ferrous Fumarate

Study type

Interventional

Funder types

Other

Identifiers

NCT02831712

13-093

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

21 to 55 years old

Volunteers

Accepts Healthy Volunteers

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)]