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

July 15, 2016 updated by: Thomas Walczyk
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • National University of Singapore; National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Iron supplement
Ferrous Fumarate tablet 200 mg
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of NTBI after an oral iron load
Time Frame: 2 hour post dose
Blood samples collected 2 h after the iron supplement consumption will be measured for NTBI concentration
2 hour post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dependence of NTBI concentration on markers of iron status (concentrations of serum iron, serum ferritin, transferrin saturation)
Time Frame: 2 hour post dose
Correlation between NTBI concentration and iron status indicators will be evaluated
2 hour post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Walczyk

Investigators

  • Principal Investigator: Thomas Walczyk, Ph.D, National University of Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

July 11, 2016

First Submitted That Met QC Criteria

July 11, 2016

First Posted (ESTIMATE)

July 13, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 15, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-093

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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