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

NCT ID: NCT01733979

Last Updated: 2019-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-07

Study Completion Date

2012-11-14

Brief Summary

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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.

Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Heme-Iron Polypeptide

Group Type EXPERIMENTAL

Heme-Iron Polypeptide

Intervention Type DIETARY_SUPPLEMENT

Heme-Iron Polypeptide (1g/day)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo (1g/day)

Heme-Iron

Group Type ACTIVE_COMPARATOR

Heme-Iron

Intervention Type DIETARY_SUPPLEMENT

Heme-Iron (1g/day)

Organic Iron

Group Type ACTIVE_COMPARATOR

Organic Iron

Intervention Type DIETARY_SUPPLEMENT

Organic Iron (1g/day)

Interventions

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Heme-Iron Polypeptide

Heme-Iron Polypeptide (1g/day)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo (1g/day)

Intervention Type DIETARY_SUPPLEMENT

Heme-Iron

Heme-Iron (1g/day)

Intervention Type DIETARY_SUPPLEMENT

Organic Iron

Organic Iron (1g/day)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo-Wan Chae

Principal Investigator, Clinical Trial Center for Functional Foods

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ABI- IDA-HIPk

Identifier Type: -

Identifier Source: org_study_id

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