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

This study is currently recruiting participants.
Verified November 2012 by Chonbuk National University Hospital
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01733979
First received: November 20, 2012
Last updated: November 26, 2012
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Anemia Iron
U.S. FDA Resources

Further study details as provided by Chonbuk National University Hospital:

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

  • Changes in transferrin saturation [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Serum iron was measured in study visit 1(0 week) and visit 5(4 week).

  • Changes in ferritin [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   19 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 20, 2012
Last Updated: November 26, 2012
Health Authority: South Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 17, 2013