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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01733979

Enrollment

Registered

2012-11-27

Start date

2012-02-07

Completion date

2012-11-14

Last updated

2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

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.

Interventions

DIETARY_SUPPLEMENTHeme-Iron Polypeptide

Heme-Iron Polypeptide (1g/day)

DIETARY_SUPPLEMENTPlacebo

Placebo (1g/day)

DIETARY_SUPPLEMENTHeme-Iron

Heme-Iron (1g/day)

DIETARY_SUPPLEMENTOrganic Iron

Organic Iron (1g/day)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026