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

Not Applicable

• Conditions: Effect of Iron Status on Occurrence of NTBI
• Interventions: Dietary Supplement: Ferrous Fumarate

• Registration Number: NCT02831712
• Lead Sponsor: Thomas Walczyk

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.

Study Timeline

• Study Start: 2013-04
• Status Verified: 2016-07
• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-13
• Last Update Submitted: 2016-07-15
• Last Update Posted: 2016-07-19
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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)]

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iron supplement	Ferrous Fumarate	Ferrous Fumarate tablet 200 mg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National University of Singapore; National University Hospital; 🇸🇬 Singapore, Singapore