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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Soo-Wan Chae, Chonbuk National University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01733979
First Posted: November 27, 2012
Last Update Posted: November 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
  Purpose
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.

Condition Intervention Phase
Anemia Dietary Supplement: Heme-Iron Polypeptide Dietary Supplement: Placebo Dietary Supplement: Heme-Iron Dietary Supplement: Organic Iron Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Soo-Wan Chae, Chonbuk National University Hospital:

Primary Outcome Measures:
  • Changes in hemoglobin [ Time Frame: 4 weeks ]
    Hemoglobin was measured in study visit 1(0 week) and visit 5(4 week).

  • Changes in transferrin saturation [ Time Frame: 4 weeks ]
    Transferrin saturation was measured in study visit 1(0 week) and visit 5(4 week).


Secondary Outcome Measures:
  • Changes in serum iron [ Time Frame: 4 weeks ]
    Serum iron was measured in study visit 1(0 week) and visit 5(4 week).

  • Changes in ferritin [ Time Frame: 4 weeks ]
    Ferritin was measured in study visit 1(0 week) and visit 5(4 week).


Estimated Enrollment: 80
Study Start Date: February 2012
Estimated Study Completion Date: December 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Heme-Iron Polypeptide Dietary Supplement: Heme-Iron Polypeptide
Heme-Iron Polypeptide (1g/day)
Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo (1g/day)
Active Comparator: Heme-Iron Dietary Supplement: Heme-Iron
Heme-Iron (1g/day)
Active Comparator: Organic Iron Dietary Supplement: Organic Iron
Organic Iron (1g/day)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733979


Locations
Korea, Republic of
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital Recruiting
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Contact: Dal-Sik Kim, MD., PhD    82-63-250-1793    dskim@chonbuk.ac.kr   
Sponsors and Collaborators
Chonbuk National University Hospital
  More Information

Responsible Party: Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01733979     History of Changes
Other Study ID Numbers: ABI- IDA-HIPk
First Submitted: November 20, 2012
First Posted: November 27, 2012
Last Update Posted: November 28, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs