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NCT Number: NCT02871128

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

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

FAO / WHO noted that iron deficiency is still an important nutritional problem. Iron deficiency problem has always been in Taiwan. This study intends to use the products, Natureheme-iron, using blood of pig to concentration, separation and extracted, and then got natural and clean Natureheme-iron. Natureheme-iron is not just a good iron supplement, while also providing an excellent source of natural protein. 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 (1000mg Fe / capsule), another group (n = 20) with the same dose of placebo, and the other group (n = 20) is a commercial iron supplement (100mg Fe). 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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

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.

Other names: latte

Primary outcomes

  1. The Hemoglobin of the Subjects at Baseline and 6 Weeks

    Time frame: 6 weeks

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

Secondary outcomes

  1. The Changes of Serum Ferritin of the Subjects.

    Time frame: 6 weeks

    values change of serum ferritin (ng/ml) between before to after 6 weeks

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study title

Evaluation of Natureheme-iron on Iron Absorption Effect and Anti-oxidation Functions- a Double-blind, Randomized, Placebo-controlled Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 18, 2016
Registry last updated
Jun 11, 2021

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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