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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014