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Completed

NCT Number: NCT01733979

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

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heme-Iron Polypeptide

Dietary Supplement

Heme-Iron Polypeptide (1g/day)

Placebo

Dietary Supplement

Placebo (1g/day)

Heme-Iron

Dietary Supplement

Heme-Iron (1g/day)

Organic Iron

Dietary Supplement

Organic Iron (1g/day)

Primary outcomes

  1. Changes in hemoglobin

    Time frame: 4 weeks

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

  2. Changes in transferrin saturation

    Time frame: 4 weeks

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

Secondary outcomes

  1. Changes in serum iron

    Time frame: 4 weeks

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

  2. Changes in ferritin

    Time frame: 4 weeks

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

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 27, 2012
Registry last updated
Aug 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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