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

Chonbuk National University

Status: Completed

Conditions: Anemia

Treatments: Dietary Supplement: Heme-Iron Polypeptide; Dietary Supplement: Placebo; Dietary Supplement: Heme-Iron; Dietary Supplement: Organic Iron

Study type: Interventional

Funder types: Other

Identifiers

NCT01733979

ABI- IDA-HIPk

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 19 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups, including a placebo group

Heme-Iron Polypeptide

Experimental group

Treatment:

Dietary Supplement: Heme-Iron Polypeptide

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo

Heme-Iron

Active Comparator group

Treatment:

Dietary Supplement: Heme-Iron

Organic Iron

Active Comparator group

Treatment:

Dietary Supplement: Organic Iron