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

Anemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733979
• Other study ID #: ABI- IDA-HIPk
• Status: Completed
• Phase: N/A
• Start date: February 7, 2012
• Est. completion date: November 14, 2012

Study information

• Verified date: August 2019
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 14, 2012
• Est. primary completion date: November 14, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia

Intervention

Dietary Supplement:
• Heme-Iron Polypeptide
Heme-Iron Polypeptide (1g/day)
• Placebo
Placebo (1g/day)
• Heme-Iron
Heme-Iron (1g/day)
• Organic Iron
Organic Iron (1g/day)

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods; Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in hemoglobin	Hemoglobin was measured in study visit 1(0 week) and visit 5(4 week).	4 weeks
Primary	Changes in transferrin saturation	Transferrin saturation was measured in study visit 1(0 week) and visit 5(4 week).	4 weeks
Secondary	Changes in serum iron	Serum iron was measured in study visit 1(0 week) and visit 5(4 week).	4 weeks
Secondary	Changes in ferritin	Ferritin was measured in study visit 1(0 week) and visit 5(4 week).	4 weeks