Clinical trial NCT02831712: Effect of Iron Status on Occurrence of Non-transferrin-bound Iron (NTBI) in Serum in Response to an Oral Iron Load
Official title: Effect of Iron Status on Occurrence of Non-transferrin-bound Iron (NTBI) in Serum in Response to an Oral Iron Load
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Effect of Iron Status on Occurrence of NTBI
Keywords: NTBI
Iron status
Iron supplement
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Concentration of NTBI after an oral iron load
timeFrame: 2 hour post dose
Secondary outcomes:
measure: Dependence of NTBI concentration on markers of iron status (concentrations of serum iron, serum ferritin, transferrin saturation)
timeFrame: 2 hour post dose
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University of Singapore; National University Hospital
Study officials:
affiliation: National University of Singapore
name: Thomas Walczyk, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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