AnemiaNCT02871128
Evaluation of Natureheme-iron on Iron Absorption Effect and Anti-oxidation Functions
A study testing Natureheme-iron and supplement in people with Anemia, run by Chung Shan Medical University.
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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- Natureheme-iron and supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible subjects were anemia men or women aged over 20 years old with Hb<=12 g/dl.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anemia
- Being tested
- Natureheme-iron, Placebo, supplement
- Keywords
- Hemoglobin, serum iron, serum ferritin, Hematocrit, antioxidant
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natureheme-ironDietary 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.
PlaceboDietary 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.
supplementDrug
Also called latte
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.
| Study group | Role | What they receive |
|---|---|---|
| Natureheme-iron | Experimental | Subjects receive 2 capsules per day containing either 1000 mg Fe. Receives: Dietary Supplement: Natureheme-iron |
| Placebo | Placebo comparator | Subjects receive 2 capsules per day containing starch placebo of similar appearance. Receives: Dietary Supplement: Placebo |
| supplement | Active comparator | Subjects receive 1 capsule per day containing either 100 mg Fe. Receives: Drug: supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
The Changes of Serum Ferritin of the Subjects.
values change of serum ferritin (ng/ml) between before to after 6 weeks
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startJul 2015
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, You-Cheng Shen, Chung Shan Medical University
- Investigators
- You-Cheng Mr Shen, Ph.D., Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871128
- Sponsor's protocol ID
- CS14135
- Other IDs
- MOST 104-2622-E-040-002 -CC2
- Status last verified
- May 2021
- First submitted
- 15 Aug 2016
- Last updated
- 11 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 10820087
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Natureheme-iron on Iron Absorption Effect and Anti-oxidation Functions- a Double-blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02871128
- Acronym / sponsor ID
- CS14135
- Conditions
- Anemia
- Keywords
- Hemoglobin, serum iron, serum ferritin, Hematocrit, antioxidant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Aug 2016 (estimated)
- Results
- Posted 28 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Natureheme-iron | Experimental | Dietary Supplement: Natureheme-ironSubjects receive 2 capsules per day containing either 1000 mg Fe. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSubjects receive 2 capsules per day containing starch placebo of similar appearance. |
| supplement | Active comparator | Drug: supplementSubjects receive 1 capsule per day containing either 100 mg Fe. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible subjects were anemia men or women aged over 20 years old with Hb<=12 g/dl.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natureheme-ironAn 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. | Dietary supplement | Natureheme-iron |
| PlaceboAn 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. | Dietary supplement | Placebo |
| supplementAlso: latteAn 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. | Drug | supplement |
Primary outcome
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.
1 secondary outcome
The Changes of Serum Ferritin of the Subjects.
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10820087Shaw 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
You-Cheng Mr Shen, Ph.D. principal investigator
Chung Shan Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Natureheme-iron and supplement in people with Anemia, run by Chung Shan Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Hemoglobin of the Subjects at Baseline and 6 Weeks (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02871128, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.