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Efficacy and Safety of Heme-Iron Polypeptide on Improvement of Anemia

Primary Purpose

Anemia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Heme-Iron Polypeptide
Placebo
Heme-Iron
Organic Iron
Sponsored by
Chonbuk National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anemia

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Males and females 19-60 years old
  • Hemoglobin concentration less than 13g/dL(men), 12g/dL(women)
  • Able to give informed consent

Exclusion Criteria:

  • Allergic or hypersensitive to any of the ingredients in the test products
  • History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
  • Participation in any other clinical trials within past 2 months
  • History of alcohol or substance abuse
  • Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
  • Pregnant or lactating women etc.

Sites / Locations

  • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Heme-Iron Polypeptide

Placebo

Heme-Iron

Organic Iron

Arm Description

Outcomes

Primary Outcome Measures

Changes in hemoglobin
Hemoglobin was measured in study visit 1(0 week) and visit 5(4 week).
Changes in transferrin saturation
Transferrin saturation was measured in study visit 1(0 week) and visit 5(4 week).

Secondary Outcome Measures

Changes in serum iron
Serum iron was measured in study visit 1(0 week) and visit 5(4 week).
Changes in ferritin
Ferritin was measured in study visit 1(0 week) and visit 5(4 week).

Full Information

First Posted
November 20, 2012
Last Updated
August 21, 2019
Sponsor
Chonbuk National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01733979
Brief Title
Efficacy and Safety of Heme-Iron Polypeptide on Improvement of Anemia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 7, 2012 (Actual)
Primary Completion Date
November 14, 2012 (Actual)
Study Completion Date
November 14, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators performed a 4-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Heme-Iron Polypeptide on Improvement of Anemia. The investigators measured Improvement of Anemia parameters , including hemoglobin, transferrin saturation, serum iron, and ferritin, and monitored their blood pressure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heme-Iron Polypeptide
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Heme-Iron
Arm Type
Active Comparator
Arm Title
Organic Iron
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Heme-Iron Polypeptide
Intervention Description
Heme-Iron Polypeptide (1g/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo (1g/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Heme-Iron
Intervention Description
Heme-Iron (1g/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Organic Iron
Intervention Description
Organic Iron (1g/day)
Primary Outcome Measure Information:
Title
Changes in hemoglobin
Description
Hemoglobin was measured in study visit 1(0 week) and visit 5(4 week).
Time Frame
4 weeks
Title
Changes in transferrin saturation
Description
Transferrin saturation was measured in study visit 1(0 week) and visit 5(4 week).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Changes in serum iron
Description
Serum iron was measured in study visit 1(0 week) and visit 5(4 week).
Time Frame
4 weeks
Title
Changes in ferritin
Description
Ferritin was measured in study visit 1(0 week) and visit 5(4 week).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males and females 19-60 years old Hemoglobin concentration less than 13g/dL(men), 12g/dL(women) Able to give informed consent Exclusion Criteria: Allergic or hypersensitive to any of the ingredients in the test products History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery Participation in any other clinical trials within past 2 months History of alcohol or substance abuse Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study Pregnant or lactating women etc.
Facility Information:
Facility Name
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
560-822
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Heme-Iron Polypeptide on Improvement of Anemia

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