Iron Supplements for Iron-Deficiency Anemia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Anil K. Gupta Medicine Professional Corporation

Must not be taking: Proton pump inhibitors, anticoagulants

Disqualifiers: Hematological disorders, chronic renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

111 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: FeraMAX Active Control 1 Intervention

Polysaccharide Iron - 150mg

Group II: Eurofer Active Control 1 Intervention

Ferrous Fumarate - 300 mg

Group III: EBMfer Active Control 1 Intervention

Ferrous Ascorbate - 100 mg

Who Is Running the Clinical Trial?

Dr. Anil K. Gupta Medicine Professional Corporation

Lead Sponsor

Trials

1

Recruited

110+