Effect of Iron Status on Occurrence of NTBI Clinical Trial
Official title:
Effect of Iron Status on Occurrence of Non-transferrin-bound Iron (NTBI) in Serum in Response to an Oral Iron Load
| Verified date | July 2016 |
| Source | National University, Singapore |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Singapore: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 50 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 21 Years to 55 Years |
| Eligibility |
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)] |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
| Country | Name | City | State |
|---|---|---|---|
| Singapore | National University of Singapore; National University Hospital | Singapore |
| Lead Sponsor | Collaborator |
|---|---|
| Thomas Walczyk |
Singapore,
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* Note: There are 12 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Concentration of NTBI after an oral iron load | Blood samples collected 2 h after the iron supplement consumption will be measured for NTBI concentration | 2 hour post dose | No |
| Secondary | Dependence of NTBI concentration on markers of iron status (concentrations of serum iron, serum ferritin, transferrin saturation) | Correlation between NTBI concentration and iron status indicators will be evaluated | 2 hour post dose | No |