Evaluation of Natureheme-iron on Iron Absorption Effect and Anti-oxidation Functions
May 20, 2021 updated by: You-Cheng Shen, Chung Shan Medical University
Evaluation of Natureheme-iron on Iron Absorption Effect and Anti-oxidation Functions- a Double-blind, Randomized, Placebo-controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Natureheme-iron
Subjects receive 2 capsules per day containing either 1000 mg Fe.
|
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 Comparator: Placebo
Subjects receive 2 capsules per day containing starch placebo of similar appearance.
|
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.
|
|
Active Comparator: supplement
Subjects receive 1 capsule per day containing either 100 mg Fe.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
August 15, 2016
First Submitted That Met QC Criteria
August 15, 2016
First Posted (Estimate)
August 18, 2016
Study Record Updates
Last Update Posted (Actual)
June 11, 2021
Last Update Submitted That Met QC Criteria
May 20, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- CS14135
- MOST 104-2622-E-040-002 -CC2 (Other Grant/Funding Number: Ministry of Science and Technology)
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