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

Not Applicable

Completed

• Conditions: Anemia
• Interventions: Dietary Supplement: Heme-Iron Polypeptide; Dietary Supplement: Placebo; Dietary Supplement: Heme-Iron; Dietary Supplement: Organic Iron

• Registration Number: NCT01733979
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-07
• Primary Completion: 2012-11-14
• Study Completion: 2012-11-14
• Study First Submitted: 2012-11-20
• Study First Submitted QC: 2012-11-21
• Study First Posted: 2012-11-27
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-21
• Last Update Posted: 2019-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heme-Iron Polypeptide	Heme-Iron Polypeptide	-
Placebo	Placebo	-
Heme-Iron	Heme-Iron	-
Organic Iron	Organic Iron	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of