NCT01733979

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
Last Updated

August 26, 2019

Status Verified

August 1, 2019

Enrollment Period

9 months

First QC Date

November 20, 2012

Last Update Submit

August 21, 2019

Conditions

Anemia

Outcome Measures

Primary Outcomes (2)

  • Changes in hemoglobin

    Hemoglobin was measured in study visit 1(0 week) and visit 5(4 week).

    4 weeks

  • Changes in transferrin saturation

    Transferrin saturation was measured in study visit 1(0 week) and visit 5(4 week).

    4 weeks

Secondary Outcomes (2)

  • Changes in serum iron

    4 weeks

  • Changes in ferritin

    4 weeks

Study Arms (4)

Heme-Iron Polypeptide

EXPERIMENTAL
Dietary Supplement: Heme-Iron Polypeptide

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Heme-Iron

ACTIVE COMPARATOR
Dietary Supplement: Heme-Iron

Organic Iron

ACTIVE COMPARATOR
Dietary Supplement: Organic Iron

Interventions

Heme-Iron PolypeptideDIETARY_SUPPLEMENT

Heme-Iron Polypeptide (1g/day)

Heme-Iron Polypeptide
PlaceboDIETARY_SUPPLEMENT

Placebo (1g/day)

Placebo
Heme-IronDIETARY_SUPPLEMENT

Heme-Iron (1g/day)

Heme-Iron
Organic IronDIETARY_SUPPLEMENT

Organic Iron (1g/day)

Organic Iron

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females 19-60 years old
  • Hemoglobin concentration less than 13g/dL(men), 12g/dL(women)
  • Able to give informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

Location

MeSH Terms

Conditions

Anemia

Interventions

Nonheme Iron Proteins

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Iron-Binding ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsMetalloproteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Trial Center for Functional Foods

Study Record Dates

First Submitted

November 20, 2012

First Posted

November 27, 2012

Study Start

February 7, 2012

Primary Completion

November 14, 2012

Study Completion

November 14, 2012

Last Updated

August 26, 2019

Record last verified: 2019-08

Locations

KR(1)