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

Sponsors

Lead Sponsor: Chonbuk National University Hospital

Source 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.

Overall Status Completed
Start Date February 7, 2012
Completion Date November 14, 2012
Primary Completion Date November 14, 2012
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Changes in hemoglobin 4 weeks
Changes in transferrin saturation 4 weeks
Secondary Outcome
Measure Time Frame
Changes in serum iron 4 weeks
Changes in ferritin 4 weeks
Enrollment 80
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Heme-Iron Polypeptide

Description: Heme-Iron Polypeptide (1g/day)

Arm Group Label: Heme-Iron Polypeptide

Intervention Type: Dietary Supplement

Intervention Name: Placebo

Description: Placebo (1g/day)

Arm Group Label: Placebo

Intervention Type: Dietary Supplement

Intervention Name: Heme-Iron

Description: Heme-Iron (1g/day)

Arm Group Label: Heme-Iron

Intervention Type: Dietary Supplement

Intervention Name: Organic Iron

Description: Organic Iron (1g/day)

Arm Group Label: Organic Iron

Eligibility

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.

Gender: All

Minimum Age: 19 Years

Maximum Age: 60 Years

Healthy Volunteers: Accepts Healthy Volunteers

Location
Facility: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Location Countries

Korea, Republic of

Verification Date

August 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Chonbuk National University Hospital

Investigator Full Name: Soo-Wan Chae

Investigator Title: Principal Investigator, Clinical Trial Center for Functional Foods

Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Heme-Iron Polypeptide

Type: Experimental

Label: Placebo

Type: Placebo Comparator

Label: Heme-Iron

Type: Active Comparator

Label: Organic Iron

Type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov