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

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ClinicalTrials.gov Identifier: NCT01733979
Recruitment Status : Unknown
Verified November 2012 by Soo-Wan Chae, Chonbuk National University Hospital.
Recruitment status was:  Recruiting
First Posted : November 27, 2012
Last Update Posted : November 28, 2012
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : February 2012
Primary Completion Date : February 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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)



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

  2. 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 :
  1. Changes in serum iron [ Time Frame: 4 weeks ]
    Serum iron was measured in study visit 1(0 week) and visit 5(4 week).

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



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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.

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

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 Posted: November 27, 2012    Key Record Dates
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