Evaluating the Effectiveness of Various Iron Salts in Oral Iron Therapy for Iron Deficiency and Anemia in Healthy Adults

Liaquat University of Medical & Health Sciences

Status: Active, not recruiting

Conditions: Iron Deficiency Anemia; Iron Deficiency

Treatments: Dietary Supplement: Oral Ferric maltol; Dietary Supplement: Oral Sucrosomial iron

Study type: Interventional

Funder types: Other

Identifiers

NCT05985070

LUMHS/REC/-86

Details and patient eligibility

About

Oral iron supplements are a cornerstone therapy for treating iron deficiency and iron deficiency anemia, aiming to replenish low iron levels in the body. These supplements typically contain various iron salts, such as ferrous sulfate, ferric maltol, ferrous gluconate, and ferric pyrophosphate.

Advancements in carrier systems, such as microencapsulation or complexation can enhance the absorption and bioavailability of iron supplements. By improving absorption, these carrier systems may mitigate gastrointestinal side effects and increase the efficacy of iron therapy.

Full description

This multicenter, randomized, double-blind parallel-group, clinical trial study aims to conduct a comparative analysis of the effectiveness of oral ferric maltose, vs Sucrosomial iron. The study seeks to evaluate their efficacy in treating iron deficiency or iron deficiency anemia, two prevalent conditions associated with low iron levels in the body. This research aims to provide valuable insights into potential difference in these two iron supplement formulations, both in terms of relative effectiveness and potential GI side effects. This comparative analysis may guide healthcare providers in selecting the most suitable oral iron supplement based on individual patient characteristics, ultimately optimizing treatment outcomes and improving patient care.

Enrollment: 59 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Adults aged 18-65 years
• Iron deficiency, defined as low serum iron <50 µg/dL, ferritin <20 ng/mL, and TIBC >400 µg/dL.
• Able and willing to provide informed consent
• Willing to comply with oral supplementation and study follow-up

Exclusion criteria

• Severe anemia, defined as hemoglobin (Hb) <8 g/dL, requiring urgent intervention
• Known malabsorption syndromes (e.g., celiac disease, IBD)
• Active bleeding or blood transfusion within the past 3 months
• Pregnancy or lactation
• Use of iron supplements within the past 4 weeks
• Known allergy or intolerance to oral iron formulations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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59 participants in 2 patient groups

Intervention Arm 1

Experimental group

Description:

Subjects in this arm will receive an oral Sucrosomial 30mg elemental iron supplement, twice daily, for 6 weeks.

Treatment:

Dietary Supplement: Oral Sucrosomial iron

Intervention Arm 2

Active Comparator group

Description:

Subjects in this arm will receive an oral Ferric maltol 30mg elemental iron supplement, twice daily, for 6 weeks.

Treatment:

Dietary Supplement: Oral Ferric maltol