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

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.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Dietary supplement: Heme-Iron Polypeptide; Dietary supplement: Placebo; Dietary supplement: Heme-Iron; Dietary supplement: Organic Iron

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
      • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo (1g/day)
Experimental: Heme-Iron Polypeptide	Dietary supplement: Heme-Iron Polypeptide; Heme-Iron Polypeptide (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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in hemoglobin	Hemoglobin was measured in study visit 1(0 week) and visit 5(4 week).	4 weeks
Changes in transferrin saturation	Transferrin saturation was measured in study visit 1(0 week) and visit 5(4 week).	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in serum iron	Serum iron was measured in study visit 1(0 week) and visit 5(4 week).	4 weeks
Changes in ferritin	Ferritin was measured in study visit 1(0 week) and visit 5(4 week).	4 weeks

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2012
• Primary Completion (Actual): November 14, 2012
• Study Completion (Actual): November 14, 2012

Study Registration Dates

• First Submitted: November 20, 2012
• First Submitted That Met QC Criteria: November 21, 2012
• First Posted (Estimate): November 27, 2012

Study Record Updates

• Last Update Posted (Actual): August 26, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: ABI- IDA-HIPk

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No