Iron Supplements for Iron-Deficiency Anemia

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Dr. Anil K. Gupta Medicine Professional Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares different iron supplements to determine which best boosts hemoglobin levels in individuals with iron-deficiency anemia. It evaluates Ferrous Ascorbate, Ferrous Fumarate, and Polysaccharide Iron to identify which is more effective and easier to tolerate. This trial suits those diagnosed with iron-deficiency anemia who are not currently taking iron supplements. Participants must be willing to discontinue any current iron treatments during the study. As an unphased trial, it offers a unique opportunity to contribute to valuable research that could enhance future treatment options for iron-deficiency anemia.

Do I have to stop taking my current medications for the trial?

Yes, if you are currently taking an iron supplement, you must stop it when you sign the consent form and throughout the study. Additionally, you cannot take certain other medications like Proton Pump Inhibitors or multivitamins with high iron content during the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ferrous fumarate is generally safe for treating iron deficiency, including for pregnant women. However, excessive intake can lead to serious iron poisoning, so following the recommended doses is crucial.

Ferrous ascorbate is also well-tolerated and often used for mild to moderate iron deficiency anemia. The body easily absorbs it, and it has no major food interactions, making it simple to include in a daily routine.

Studies have shown that polysaccharide iron, such as FeraMAX, is safe and has a safety profile similar to other iron treatments. However, individuals with certain conditions, like hemochromatosis (where the body absorbs too much iron), should avoid it.

Overall, research indicates that these iron supplements are safe when used correctly. Always adhere to the provided guidelines to avoid any side effects.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for iron-deficiency anemia because they offer unique formulations that might improve iron absorption and reduce side effects compared to standard options like ferrous sulfate. Ferrous Ascorbate (EBMfer) combines iron with ascorbic acid, which can enhance iron absorption in the body. Ferrous Fumarate (Eurofer) is another form of iron that is well-absorbed and may be easier on the stomach for some patients. Polysaccharide Iron (FeraMAX) features a different delivery method that encapsulates iron in a complex carbohydrate, potentially reducing gastrointestinal irritation. Each of these treatments provides a fresh approach to managing iron levels more effectively and comfortably.

What evidence suggests that this trial's treatments could be effective for iron-deficiency anemia?

This trial will compare different iron supplements for treating iron-deficiency anemia (IDA). Research has shown that ferrous ascorbate, which participants may receive, effectively increases hemoglobin levels. Studies indicate it can significantly raise hemoglobin levels compared to other iron supplements. Ferrous fumarate, another treatment option in this trial, has also demonstrated strong results, with notable improvements in hemoglobin and ferritin levels after 90 days. Additionally, polysaccharide iron, also tested in this trial, has proven effective, with results showing up to 99% improvement in maintaining iron levels. All these treatments are good options for managing IDA.13467

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older who are dealing with iron deficiency anemia. Participants should have a confirmed diagnosis of IDA and be willing to take oral iron supplements. Specific details about what might exclude someone from participating aren't provided, but typically these criteria would involve health conditions that could interfere with the study or risk participant safety.

Inclusion Criteria

Must have given written informed consent (signed and dated)
My sex and contraceptive use do not affect my eligibility.
Protocol Compliance: Participants must be able to comply with the requirements outlined in the study protocol
See 2 more

Exclusion Criteria

I have a condition that affects how my body absorbs iron.
History of occult blood in the stool
I am not taking any iron supplements during the study.
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral treatment with either Ferrous Ascorbate, Ferrous Fumarate, or Polysaccharide Iron for 12 weeks to assess changes in hemoglobin levels

12 weeks
Baseline and 12-week visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ferrous Ascorbate
  • Ferrous Fumarate
  • Polysaccharide Iron
Trial Overview The trial is testing three different types of iron supplements: Ferrous Ascorbate (EBMfer), Ferrous Fumarate (Eurofer), and Polysaccharide Iron (FeraMax). It aims to find out which one raises hemoglobin levels best over a period of three months, considering both effectiveness and tolerability.
How Is the Trial Designed?
3Treatment groups
Active Control
Group I: FeraMAXActive Control1 Intervention
Group II: EuroferActive Control1 Intervention
Group III: EBMferActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dr. Anil K. Gupta Medicine Professional Corporation

Lead Sponsor

Trials
1
Recruited
110+

Citations

Comparison of the effectiveness of ferrous ascorbate with ...The above studies, including the present study, concluded that ferrous ascorbate significantly improves Hb percentages compared to other iron ...
Efficacy of vitamin C with Fe supplementation in patients ...The results of this study do not support routine supplementation of oral iron therapy with vitamin C in the treatment of IDA.
Ferrous Ascorbate: Current Clinical Place of Therapy in the ...Ferrous ascorbate can help to combat the huge burden of anemia by providing an effective option to synthesize and restore Hb as iron deficiency is the most ...
NCT05957328 | A Study to Compare Liposomal Iron With ...Research Hypothesis: Liposomal iron preparation is equally effective and more tolerable than ferrous ascorbate in treating iron deficiency anemia in 6 to 59 ...
A clinical study evaluating low dose ferrous fumarate vs. ...After a 90-day treatment period, statistically significant improvements were observed in the mean hemoglobin and ferritin levels in both the ...
The Efficacy and Safety of Vitamin C for Iron ...These findings suggest that on-demand vitamin C supplements are not essential to take along with oral iron supplements for patients with IDA.
Comparison of efficacy & safety of iron polymaltose ...The results of the study showed that FS, IPC and FeA have comparable efficacy and safety profile in the treatment of IDA of pregnancy.
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