AnemiaNCT01733979
Efficacy and Safety of Heme-Iron Polypeptide on Improvement of Anemia
A study testing Heme-Iron Polypeptide, Heme-Iron and Organic Iron in people with Anemia, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
The investigators performed a 4-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Heme-Iron Polypeptide on Improvement of Anemia. Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- Heme-Iron Polypeptide, Heme-Iron and Organic Iron
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Feb 2012to 14 Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females 19-60 years old
- Hemoglobin concentration less than 13g/dL(men), 12g/dL(women)
- Able to give informed consent
Who cannot join
- Allergic or hypersensitive to any of the ingredients in the test products
- History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
- Participation in any other clinical trials within past 2 months
- History of alcohol or substance abuse
- Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
- Pregnant or lactating women etc.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 560-822
About this study
The investigators performed a 4-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Heme-Iron Polypeptide on Improvement of Anemia. The investigators measured Improvement of Anemia parameters , including hemoglobin, transferrin saturation, serum iron, and ferritin, and monitored their blood pressure.
- Conditions
- Anemia
- Being tested
- Heme-Iron Polypeptide, Placebo, Heme-Iron, Organic Iron
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heme-Iron PolypeptideDietary supplement
Heme-Iron Polypeptide (1g/day)
PlaceboDietary supplement
Placebo (1g/day)
Heme-IronDietary supplement
Heme-Iron (1g/day)
Organic IronDietary supplement
Organic Iron (1g/day)
| Study group | Role | What they receive |
|---|---|---|
| Heme-Iron Polypeptide | Experimental | Not described Receives: Dietary Supplement: Heme-Iron Polypeptide |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Heme-Iron | Active comparator | Not described Receives: Dietary Supplement: Heme-Iron |
| Organic Iron | Active comparator | Not described Receives: Dietary Supplement: Organic Iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in hemoglobin
Hemoglobin was measured in study visit 1(0 week) and visit 5(4 week).
Measured: 4 weeks
Changes in transferrin saturation
Transferrin saturation was measured in study visit 1(0 week) and visit 5(4 week).
Measured: 4 weeks
Secondary outcomes (2)
Changes in serum iron
Serum iron was measured in study visit 1(0 week) and visit 5(4 week).
Measured: 4 weeks
Changes in ferritin
Ferritin was measured in study visit 1(0 week) and visit 5(4 week).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study start7 Feb 2012
- Primary completion14 Nov 2012
- Study completion14 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733979
- Sponsor's protocol ID
- ABI- IDA-HIPk
- Status last verified
- Aug 2019
- First submitted
- 20 Nov 2012
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Heme-Iron Polypeptide on Improvement of Anemia
- ClinicalTrials.gov ID
- NCT01733979
- Acronym / sponsor ID
- ABI- IDA-HIPk
- Conditions
- Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- 7 Feb 2012 (actual)
- Primary completion
- 14 Nov 2012 (actual)
- Study completion
- 14 Nov 2012 (actual)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators performed a 4-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Heme-Iron Polypeptide on Improvement of Anemia. The investigators measured Improvement of Anemia parameters , including hemoglobin, transferrin saturation, serum iron, and ferritin, and monitored their blood pressure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Heme-Iron Polypeptide | Experimental | Dietary Supplement: Heme-Iron Polypeptide |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Heme-Iron | Active comparator | Dietary Supplement: Heme-Iron |
| Organic Iron | Active comparator | Dietary Supplement: Organic Iron |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males and females 19-60 years old
- Hemoglobin concentration less than 13g/dL(men), 12g/dL(women)
- Able to give informed consent
Key exclusion criteria (6 listed)
- Allergic or hypersensitive to any of the ingredients in the test products
- History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
- Participation in any other clinical trials within past 2 months
- History of alcohol or substance abuse
- Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
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 |
|---|---|---|
| Heme-Iron PolypeptideHeme-Iron Polypeptide (1g/day) | Dietary supplement | Heme-Iron Polypeptide |
| PlaceboPlacebo (1g/day) | Dietary supplement | Placebo |
| Heme-IronHeme-Iron (1g/day) | Dietary supplement | Heme-Iron |
| Organic IronOrganic Iron (1g/day) | Dietary supplement | Organic Iron |
Primary outcome
Changes in hemoglobin
Time frame: 4 weeks
Hemoglobin was measured in study visit 1(0 week) and visit 5(4 week).
Changes in transferrin saturation
Time frame: 4 weeks
Transferrin saturation was measured in study visit 1(0 week) and visit 5(4 week).
2 secondary outcomes
Changes in serum iron
Time frame: 4 weeks
Changes in ferritin
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heme-Iron Polypeptide, Heme-Iron and Organic Iron in people with Anemia, run by Chonbuk National University Hospital at 1 site in South Korea.
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 3 inclusion and 6 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 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in hemoglobin (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2019.