Iron Deficiency AnemiaNCT01380548
Effects of 5-Aminolevulinic Acid on Iron Deficiency Anemia
A study testing Iron alone, Low-dose 5-aminolevulinic acid with iron and Medium-dose 5-aminolevulinic acid with iron in people with Iron Deficiency Anemia, run by Hiroshima University at 1 site in Japan.
Trial summary
This study is designed to evaluate efficacy and dose-dependency of 5-aminolevulinic acid in subjects with iron deficiency anemia. Read more about this study
- Who is it for?
- Ages 20 to 49 years, women only
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Iron alone, Low-dose 5-aminolevulinic acid with iron and Medium-dose 5-aminolevulinic acid with iron
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2011to Dec 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 20 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal women with hemoglobin ≥ 9.0 g/dl and ≤ 12.0 g/dl
- Willing not to donate blood during the study
- Informed consent signed
Who cannot join
- History of porphyria, hemochromatosis, or viral hepatitis
- Anemia other than iron deficiency
- BMI ≤ 18 kg/m2 or ≥ 30 kg/m2
- Pregnant or nursing a child
- Participation in any clinical trial within 90 days of the commencement of the trial
- Renal or hepatic dysfunction
- Heart disease
- Subjects who are taking medicines or functional food that may affect hemoglobin level
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo Controlled Study to Assess Efficacy of 5-Aminolevulinic Acid in Subjects With Iron Deficiency Anemia
This study is designed to evaluate efficacy and dose-dependency of 5-aminolevulinic acid in subjects with iron deficiency anemia.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Placebo, Iron alone, Low-dose 5-aminolevulinic acid with iron, Medium-dose 5-aminolevulinic acid with iron, High-dose 5-aminolevulinic acid with iron
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Placebo; once/day; for 12 weeks
Iron aloneDietary supplement
Iron (3 mg); once/day; for 12 weeks
Low-dose 5-aminolevulinic acid with ironDietary supplement
5-Aminolevulinic acid (12.5 mg) and iron (3 mg); once/day; for 12 weeks
Medium-dose 5-aminolevulinic acid with ironDietary supplement
5-Aminolevulinic acid (25 mg) and iron (3 mg); once/day; for 12 weeks
High-dose 5-aminolevulinic acid with ironDietary supplement
5-Aminolevulinic acid (50 mg) and iron (3 mg); once/day; for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Iron alone | Placebo comparator | Not described Receives: Dietary Supplement: Iron alone |
| Low-dose 5-aminolevulinic acid | Experimental | Not described Receives: Dietary Supplement: Low-dose 5-aminolevulinic acid with iron |
| Medium-dose 5-aminolevulinic acid | Experimental | Not described Receives: Dietary Supplement: Medium-dose 5-aminolevulinic acid with iron |
| High-dose 5-aminolevulinic acid | Experimental | Not described Receives: Dietary Supplement: High-dose 5-aminolevulinic acid with iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin level
Measured: Every 4 weeks (Overall 20 weeks)
Secondary outcomes (10)
Serum ferritin level
Measured: Every 4 weeks (Overall 20 weeks)
Transferrin level
Measured: Every 4 weeks (Overall 20 weeks)
MCV level
Measured: Every 4 weeks (Overall 20 weeks)
TIBC level
Measured: Every 4 weeks (Overall 20 weeks)
Reticulocyte level
Measured: Every 4 weeks (Overall 20 weeks)
Red blood cell level
Measured: Every 4 weeks (Overall 20 weeks)
Hematocrit level
Measured: Every 4 weeks (Overall 20 weeks)
Serum iron level
Measured: Every 4 weeks (Overall 20 weeks)
Soluble transferrin receptor level
Measured: Week 0 (baseline) and Week 12
Hepcidin-25 level
Measured: Week 0 (baseline) and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency 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, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hiroshima University
- Sponsor type
- University, hospital or other
- Collaborators
- SBI ALApromo Co., Ltd., Japan
- Responsible party
- Principal investigator, Fumiko Higashikawa, Hiroshima University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380548
- Sponsor's protocol ID
- eki-396
- Status last verified
- Mar 2013
- First submitted
- 21 Jun 2011
- Last updated
- 28 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo Controlled Study to Assess Efficacy of 5-Aminolevulinic Acid in Subjects With Iron Deficiency Anemia
- ClinicalTrials.gov ID
- NCT01380548
- Acronym / sponsor ID
- eki-396
- Conditions
- Iron Deficiency Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Hiroshima UniversityUniversity, hospital or other
- Collaborators
- SBI ALApromo Co., Ltd., Japan
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Jun 2011 (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.
This study is designed to evaluate efficacy and dose-dependency of 5-aminolevulinic acid in subjects with iron deficiency anemia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Iron alone | Placebo comparator | Dietary Supplement: Iron alone |
| Low-dose 5-aminolevulinic acid | Experimental | Dietary Supplement: Low-dose 5-aminolevulinic acid with iron |
| Medium-dose 5-aminolevulinic acid | Experimental | Dietary Supplement: Medium-dose 5-aminolevulinic acid with iron |
| High-dose 5-aminolevulinic acid | Experimental | Dietary Supplement: High-dose 5-aminolevulinic acid with iron |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Premenopausal women with hemoglobin ≥ 9.0 g/dl and ≤ 12.0 g/dl
- Willing not to donate blood during the study
- Informed consent signed
Key exclusion criteria (8 listed)
- History of porphyria, hemochromatosis, or viral hepatitis
- Anemia other than iron deficiency
- BMI ≤ 18 kg/m2 or ≥ 30 kg/m2
- Pregnant or nursing a child
- Participation in any clinical trial within 90 days of the commencement of the trial
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 |
|---|---|---|
| PlaceboPlacebo; once/day; for 12 weeks | Dietary supplement | Placebo |
| Iron aloneIron (3 mg); once/day; for 12 weeks | Dietary supplement | Iron alone |
| Low-dose 5-aminolevulinic acid with iron5-Aminolevulinic acid (12.5 mg) and iron (3 mg); once/day; for 12 weeks | Dietary supplement | Low-dose 5-aminolevulinic acid |
| Medium-dose 5-aminolevulinic acid with iron5-Aminolevulinic acid (25 mg) and iron (3 mg); once/day; for 12 weeks | Dietary supplement | Medium-dose 5-aminolevulinic acid |
| High-dose 5-aminolevulinic acid with iron5-Aminolevulinic acid (50 mg) and iron (3 mg); once/day; for 12 weeks | Dietary supplement | High-dose 5-aminolevulinic acid |
Primary outcome
Hemoglobin level
Time frame: Every 4 weeks (Overall 20 weeks)
10 secondary outcomes
Serum ferritin level
Time frame: Every 4 weeks (Overall 20 weeks)
Transferrin level
Time frame: Every 4 weeks (Overall 20 weeks)
MCV level
Time frame: Every 4 weeks (Overall 20 weeks)
TIBC level
Time frame: Every 4 weeks (Overall 20 weeks)
Reticulocyte level
Time frame: Every 4 weeks (Overall 20 weeks)
Red blood cell level
Time frame: Every 4 weeks (Overall 20 weeks)
Hematocrit level
Time frame: Every 4 weeks (Overall 20 weeks)
Serum iron level
Time frame: Every 4 weeks (Overall 20 weeks)
Soluble transferrin receptor level
Time frame: Week 0 (baseline) and Week 12
Hepcidin-25 level
Time frame: Week 0 (baseline) and Week 12
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 28 Mar 2013.
Related trials for Iron Deficiency Anemia
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
Iron Deficiency Anemia, Parenting Intervention
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 Iron alone, Low-dose 5-aminolevulinic acid with iron and Medium-dose 5-aminolevulinic acid with iron in people with Iron Deficiency Anemia, run by Hiroshima University at 1 site in Japan.
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 8 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 28 Mar 2013. 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 Japan. 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?
Hemoglobin level (time frame: Every 4 weeks (Overall 20 weeks)). 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 28 Mar 2013.