Evaluation of Natureheme-iron on Iron Absorption Effect and Anti-oxidation Functions

NCT02871128 | Completed Results DMC

• 2 other identifiers: CS14135MOST 104-2622-E-040-002 -CC2
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Iron deficiency problem has always been in Taiwan. This is a randomized, double-blind trial. Subjects separate to 3 groups, one group (n = 20) take two Natureheme-iron capsules a day for a total of 12 weeks, another group (n = 20) with the same dose of placebo, and the other group (n = 20) is a commercial iron supplement. Investigators assess whether Natureheme-iron can promote iron absorption and antioxidant effects, and compare the effects with commercial iron supplement. When this study is completed, it will increase the value of Natureheme-iron, and can improve health of Taiwanese.

Conditions

Anemia

Keywords

Hemoglobin; serum iron; serum ferritin; Hematocrit; antioxidant

Outcome Measures

Primary Outcomes (1)

• The Hemoglobin of the Subjects at Baseline and 6 Weeks

  The Hb (g/dl) measure at baseline and 6 weeks and compare the value at 6 weeks minus value at baseline.

  6 weeks

Secondary Outcomes (1)

• The Changes of Serum Ferritin of the Subjects.

  6 weeks

Study Arms (3)

Natureheme-iron

EXPERIMENTAL

Subjects receive 2 capsules per day containing either 1000 mg Fe.

Dietary Supplement: Natureheme-iron

Placebo

PLACEBO COMPARATOR

Subjects receive 2 capsules per day containing starch placebo of similar appearance.

Dietary Supplement: Placebo

supplement

ACTIVE COMPARATOR

Subjects receive 1 capsule per day containing either 100 mg Fe.

Drug: supplement

Interventions

Natureheme-iron DIETARY_SUPPLEMENT

An 12 week double-blinded randomized parallel study with 4 week follow-up period was performed in mild anemia subjects. Consenting eligible subjects were receive 2 capsules per day containing either 1000 mg Fe of similar appearance for 12 weeks. The subjects were required to visit at baseline, every 6 weeks during the intervention period (6 weeks), and at follow-up 4 weeks after treatment had ended. During each study visit, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls.

Natureheme-iron

Placebo DIETARY_SUPPLEMENT

An 12 week double-blinded randomized parallel study with 4 week follow-up period was performed in mild anemia subjects. Consenting eligible subjects were receive 2 capsules per day containing either 1000 mg starch placebo of similar appearance for 12 weeks. The subjects were required to visit at baseline, every 6 weeks during the intervention period (6 weeks), and at follow-up 4 weeks after treatment had ended. During each study visit, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls.

Placebo

supplement DRUG

An 12 week double-blinded randomized parallel study with 4 week follow-up period was performed in mild anemia subjects. Consenting eligible subjects were receive 1 capsule per day containing either 100 mg Fe of similar appearance for 12 weeks. The subjects were required to visit at baseline, every 6 weeks during the intervention period (6 weeks), and at follow-up 4 weeks after treatment had ended. During each study visit, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls.

Also known as: latte

supplement

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible subjects were anemia men or women aged over 20 years old with Hb\<=12 g/dl.

You may not qualify if:

• Subjects were excluded if subjects had a history of major cardiovascular disease, severe liver dysfunction, insulin-dependent diabetes mellitus or stroke. Subjects were also excluded if they routinely consumed alcohol, were pregnant or unable to comprehend study instructions.

Sponsors & Collaborators

• Chung Shan Medical University: lead

Related Publications (1)

• Shaw NS, Liu YH. Bioavailability of iron from purple laver (Porphyra spp.) estimated in a rat hemoglobin regeneration bioassay. J Agric Food Chem. 2000 May;48(5):1734-7. doi: 10.1021/jf990759y.

  PMID: 10820087 BACKGROUND

MeSH Terms

Conditions

Anemia

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Dr. You-Cheng Shen
• Organization: Chung Shan Medical University

youcheng@csmu.edu.tw

+886-4-24730022

Study Officials

• You-Cheng Mr Shen, Ph.D.

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: School of Health Diet and Industry Managment

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: August 18, 2016
• Study Start: July 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 11, 2021
• Results First Posted: August 28, 2020

Record last verified: 2021-05