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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02871128
• Other study ID #: CS14135
• Secondary ID: MOST 104-2622-E-
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: December 2016

Study information

• Verified date: May 2021
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia

Intervention

Dietary Supplement:
• Natureheme-iron
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
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.

Drug:
• 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 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Changes of Serum Ferritin of the Subjects.	values change of serum ferritin (ng/ml) between before to after 6 weeks	6 weeks