This trial is active, not recruiting.

Condition effect of iron status on occurrence of ntbi
Treatment ferrous fumarate
Sponsor Thomas Walczyk
Start date April 2013
End date December 2016
Trial size 50 participants
Trial identifier NCT02831712, 13-093


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose screening
Ferrous Fumarate tablet 200 mg
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 Outcomes

Concentration of NTBI after an oral iron load
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)
time frame: 2 hour post dose

Eligibility Criteria

Male or female participants from 21 years up to 55 years old.

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)]

Additional Information

Official title Effect of Iron Status on Occurrence of Non-transferrin-bound Iron (NTBI) in Serum in Response to an Oral Iron Load
Principal investigator Thomas Walczyk, Ph.D
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by National University, Singapore.