Iron Deficiency AnemiaNCT06303531
Efficacious Iron for Iron Deficiency Anemia in Adults Aged ≥18 Years
A study testing Ferrous Fumarate, Polysaccharide Iron and Ferrous Ascorbate in people with Iron Deficiency Anemia, run by Dr. Anil K. Gupta Medicine Professional Corporation at 1 site in Canada.
Trial summary
Iron deficiency anemia (IDA) is a widespread condition affecting many people globally. Despite the many cases of IDA, there are few studies that compare the effectiveness of different types of iron supplements with a greater emphasis on the cost of supplements and their tolerability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Ferrous Fumarate, Polysaccharide Iron and Ferrous Ascorbate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteCanada
- Study dates
- 24 Feb 2024to Feb 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be ≥18 years of age when signing the informed consent.
- Participants with iron deficiency anemia are defined as follows for the purpose of this study:
- Male: Hgb > 80 to ≤135g/L and Serum Ferritin < 30 ug/L Female: Hgb > 80 to ≤120g/L and Serum Ferritin < 30 ug/L 2b. Local lab done prior to 7 days can be enrolled in the trial provided all the inclusion and exclusion criteria are met.
- 2c. Previously Screen Failed subjects not meeting the <15 ug/L ferritin criteria can be rescreened once ICF is signed.
- 2d. Subjects not on iron supplement and meeting all the randomization criteria do not have to wait for 7 days for visit 2.
- 3. Sex and Contraceptive/Barrier Requirements, Male and Female participants: None 4. Must have given written informed consent (signed and dated) 5. Medication Stopping: If the participant is currently on an iron supplement, they must be willing to discontinue the medication upon signing the Informed Consent Form (ICF) and throughout the study. 6. Protocol Compliance: Participants must be able to comply with the requirements outlined in the study protocol
Who cannot join
- Hemoglobin (Hb) ≤ 80 g/L
- Medical history of current hematological disorders other than iron deficiency anemia (e.g., aplastic anemia, megaloblastic anemia, sideroblastic anemia, pernicious anemia, thalassemia trait, thalassemia, sickle cell anemia, etc.).
- Medical history of chronic renal disease, current history of any known inflammatory disorder, and any chronic medical condition that, in the opinion of the Principal Investigator, would compromise participant safety.
- Medical history or evidence of intestinal malabsorption, malabsorption syndrome, hemochromatosis, and hemosiderosis, hypochlorhydria, achlorhydria, gastrectomy, and gastrojejunostomy.
- History of occult blood in the stool.
- Obvious internal or external bleeding as documented by medical history if considered clinically significant in the investigator's opinion.
Show all 21Show fewer
- Severe and uncontrolled diseases, including serious psychological disorders, that are likely to interfere with the study.
- Significant co-morbidity, such as a severe chronic medical condition unrelated to iron deficiency that is apparent on history or laboratory tests.
- Iron Supplementation: Throughout the study duration, participants are not allowed to receive other sources of iron supplementation, including but not limited to other oral iron tablets and intravenous iron therapy.
- Prohibited Medication: Inability to withhold prohibited medications. Prohibited medications include Proton Pump Inhibitors, Cholestyramine, colestipol, and new anticoagulant therapy initiated in the past six months (e.g., warfarin, apixaban, dabigatran, edoxaban, rivaroxaban).
- Multivitamin and Mineral Supplements: Not willing to discontinue multivitamin and mineral supplements containing 35 mg or more of elemental iron per day on the day of screening and throughout the study.
- Blood Transfusion, Blood Donation, and IV Iron Therapy: History of blood transfusion, blood donation, or significant blood loss (e.g., due to an accident or surgery), or intravenous iron therapy in the past four months.
- Participants must not be currently participating in any other interventional clinical trial.
- Pregnancy: A urine dipstick pregnancy test will be performed at Visit 1, and pregnant individuals will be excluded from the study.
- Desire to Conceive Within the Next 13 weeks: This criterion includes patients who are actively trying to conceive or are receiving treatment to facilitate conception. They will be excluded from the study.
- Known or Suspected Hypersensitivity to Iron: Individuals with a known or suspected hypersensitivity to iron or any of the components of Ferrous Fumarate (Eurofer), Polysaccharide Iron (FeraMAX), and Ferrous Ascorbate (EBMfer) will be excluded.
- Planned Surgery: Participants with planned surgery during the study or those who had surgery within two weeks before the screening visit will be excluded.
- Difficulties with Blood Sampling: Individuals with difficulties related to blood sampling that might hinder the study procedures will be excluded.
- Alcohol or Drug Abuse: Participants showing evidence of alcohol or drug abuse that, in the opinion of the investigator, could interfere with study compliance or prevent understanding of the study's objectives and procedures will be excluded.
- Inability to Follow Study Procedures: This includes individuals who are unable to follow study procedures due to factors like language problems or self-reported psychological disorders.
- Enrollment of the Investigator, Family Members, and Clinic Employees: The investigator, their family members, and clinic employees will not be eligible to participate in the study to avoid any potential conflicts of interest
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Interventional, Single-Center, Randomized, Unblinded, Parallel-Group, Three-Arm Study to Investigate the Superiority of 12 Weeks of Oral Treatment With Ferrous Ascorbate (EBMfer) or Ferrous Fumarate (Eurofer) as Compared to Polysaccharide Iron (FeraMAX) in Hemoglobin Level Changes in Adults Aged 18 and Above With Iron Deficiency Anemia (EFFICACIOUS IRON)
Iron deficiency anemia (IDA) is a widespread condition affecting many people globally. Despite the many cases of IDA, there are few studies that compare the effectiveness of different types of iron supplements with a greater emphasis on the cost of supplements and their tolerability. This study aims to conduct a comparison between different iron supplements to determine the superiority of the iron supplements Ferrous Ascorbate (EBMfer) and Ferrous Fumarate (Eurofer) over polysaccharide iron (FeraMax). This comparison will be conducted by determining the change in hemoglobin levels for participants in this trial over a 3-month period.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Ferrous Fumarate, Polysaccharide Iron, Ferrous Ascorbate
- Keywords
- Anemia, Iron Deficiency, Ferrous Fumarate, Polysaccharide Iron, Ferrous Ascorbate
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous FumarateDietary supplement
Also called Eurofer
Ferrous Fumarate - 300 mg
Polysaccharide IronDietary supplement
Also called FeraMAX
Polysaccharide Iron - 150 mg
Ferrous AscorbateDietary supplement
Also called EBMfer
Ferrous Ascorbate - 100 mg
| Study group | Role | What they receive |
|---|---|---|
| Eurofer | Active comparator | Ferrous Fumarate - 300 mg Receives: Dietary Supplement: Ferrous Fumarate |
| FeraMAX | Active comparator | Polysaccharide Iron - 150mg Receives: Dietary Supplement: Polysaccharide Iron |
| EBMfer | Active comparator | Ferrous Ascorbate - 100 mg Receives: Dietary Supplement: Ferrous Ascorbate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin Levels
Hemoglobin levels measured using a hematology panel at baseline and 12 weeks
Measured: 12 Weeks from Baseline
Secondary outcomes (2)
Change in Serum Ferritin
Serum ferritin measured using a hematology panel at baseline and 12 weeks
Measured: 12 Weeks from Baseline
Tolerability of Study Medication - Discontinuation Rate
Discontinuation rates measured using subject compliance over the trial period of 12 weeks. Discontinuation rate will be measured based on subject compliance with study medication as a rate based on time.
Measured: 12 Weeks from Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start24 Feb 2024
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Anil K. Gupta Medicine Professional Corporation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303531
- Sponsor's protocol ID
- Efficacious Iron
- Status last verified
- Mar 2024
- First submitted
- 26 Feb 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ganguly S. Comparison between Ferrous Ascorbate and Colloidal Iron in the Treatment of Iron Deficiency Anemia in Children from Kolkata, India. BJMMR 2012; 2: 195-205.
Powers JM, Buchanan GR, Adix L, Zhang S, Gao A, McCavit TL. Effect of Low-Dose Ferrous Sulfate vs Iron Polysaccharide Complex on Hemoglobin Concentration in Young Children With Nutritional Iron-Deficiency Anemia: A Randomized Clinical Trial. JAMA. 2017 Jun 13;317(22):2297-2304. doi: 10.1001/jama.2017.6846.
PubMed 28609534Liu TC, Lin SF, Chang CS, Yang WC, Chen TP. Comparison of a combination ferrous fumarate product and a polysaccharide iron complex as oral treatments of iron deficiency anemia: a Taiwanese study. Int J Hematol. 2004 Dec;80(5):416-20. doi: 10.1532/ijh97.a10409.
PubMed 15646652Moe S, Grill AK, Allan GM. Newer iron supplements for anemia. Can Fam Physician. 2019 Aug;65(8):556. No abstract available.
PubMed 31413026
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional, Single-Center, Randomized, Unblinded, Parallel-Group, Three-Arm Study to Investigate the Superiority of 12 Weeks of Oral Treatment With Ferrous Ascorbate (EBMfer) or Ferrous Fumarate (Eurofer) as Compared to Polysaccharide Iron (FeraMAX) in Hemoglobin Level Changes in Adults Aged 18 and Above With Iron Deficiency Anemia (EFFICACIOUS IRON)
- ClinicalTrials.gov ID
- NCT06303531
- Acronym / sponsor ID
- Efficacious Iron
- Conditions
- Iron Deficiency Anemia
- Keywords
- Anemia, Iron Deficiency, Ferrous Fumarate, Polysaccharide Iron, Ferrous Ascorbate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Dr. Anil K. Gupta Medicine Professional CorporationResearch network
- Study start
- 24 Feb 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 12 Mar 2024 (actual)
- 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.
Iron deficiency anemia (IDA) is a widespread condition affecting many people globally. Despite the many cases of IDA, there are few studies that compare the effectiveness of different types of iron supplements with a greater emphasis on the cost of supplements and their tolerability. This study aims to conduct a comparison between different iron supplements to determine the superiority of the iron supplements Ferrous Ascorbate (EBMfer) and Ferrous Fumarate (Eurofer) over polysaccharide iron (FeraMax). This comparison will be conducted by determining the change in hemoglobin levels for participants in this trial over a 3-month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eurofer | Active comparator | Dietary Supplement: Ferrous FumarateFerrous Fumarate - 300 mg |
| FeraMAX | Active comparator | Dietary Supplement: Polysaccharide IronPolysaccharide Iron - 150mg |
| EBMfer | Active comparator | Dietary Supplement: Ferrous AscorbateFerrous Ascorbate - 100 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must be ≥18 years of age when signing the informed consent.
- Participants with iron deficiency anemia are defined as follows for the purpose of this study:
- Male: Hgb > 80 to ≤135g/L and Serum Ferritin < 30 ug/L Female: Hgb > 80 to ≤120g/L and Serum Ferritin < 30 ug/L 2b. Local lab done prior to 7 days can be enrolled in the trial provided all the inclusion and exclusion criteria are met.
- 2c. Previously Screen Failed subjects not meeting the <15 ug/L ferritin criteria can be rescreened once ICF is signed.
- 2d. Subjects not on iron supplement and meeting all the randomization criteria do not have to wait for 7 days for visit 2.
Key exclusion criteria (21 listed)
- Hemoglobin (Hb) ≤ 80 g/L
- Medical history of current hematological disorders other than iron deficiency anemia (e.g., aplastic anemia, megaloblastic anemia, sideroblastic anemia, pernicious anemia, thalassemia trait, thalassemia, sickle cell anemia, etc.).
- Medical history of chronic renal disease, current history of any known inflammatory disorder, and any chronic medical condition that, in the opinion of the Principal Investigator, would compromise participant safety.
- Medical history or evidence of intestinal malabsorption, malabsorption syndrome, hemochromatosis, and hemosiderosis, hypochlorhydria, achlorhydria, gastrectomy, and gastrojejunostomy.
- History of occult blood in the stool.
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 |
|---|---|---|
| Ferrous FumarateAlso: EuroferFerrous Fumarate - 300 mg | Dietary supplement | Eurofer |
| Polysaccharide IronAlso: FeraMAXPolysaccharide Iron - 150 mg | Dietary supplement | FeraMAX |
| Ferrous AscorbateAlso: EBMferFerrous Ascorbate - 100 mg | Dietary supplement | EBMfer |
Primary outcome
Change in Hemoglobin Levels
Time frame: 12 Weeks from Baseline
Hemoglobin levels measured using a hematology panel at baseline and 12 weeks
2 secondary outcomes
Change in Serum Ferritin
Time frame: 12 Weeks from Baseline
Tolerability of Study Medication - Discontinuation Rate
Time frame: 12 Weeks from Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- BackgroundGanguly S. Comparison between Ferrous Ascorbate and Colloidal Iron in the Treatment of Iron Deficiency Anemia in Children from Kolkata, India. BJMMR 2012; 2: 195-205.
- Background: PubMed 28609534Powers JM, Buchanan GR, Adix L, Zhang S, Gao A, McCavit TL. Effect of Low-Dose Ferrous Sulfate vs Iron Polysaccharide Complex on Hemoglobin Concentration in Young Children With Nutritional Iron-Deficiency Anemia: A Randomized Clinical Trial. JAMA. 2017 Jun 13;317(22):2297-2304. doi: 10.1001/jama.2017.6846.
- Background: PubMed 15646652Liu TC, Lin SF, Chang CS, Yang WC, Chen TP. Comparison of a combination ferrous fumarate product and a polysaccharide iron complex as oral treatments of iron deficiency anemia: a Taiwanese study. Int J Hematol. 2004 Dec;80(5):416-20. doi: 10.1532/ijh97.a10409.
- Background: PubMed 31413026Moe S, Grill AK, Allan GM. Newer iron supplements for anemia. Can Fam Physician. 2019 Aug;65(8):556. No abstract available.
- Individual participant dataSharing planned: Undecided
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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 Ferrous Fumarate, Polysaccharide Iron and Ferrous Ascorbate in people with Iron Deficiency Anemia, run by Dr. Anil K. Gupta Medicine Professional Corporation at 1 site in Canada.
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 6 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 25 Mar 2024. 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 Canada. 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. 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?
Results are not available in the source record.
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?
Change in Hemoglobin Levels (time frame: 12 Weeks from Baseline). 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 NCT06303531, which also lists 4 linked publications.
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 25 Mar 2024.