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

Evaluating the Effectiveness of Various Iron Salts in Oral Iron Therapy for Iron Deficiency and Anemia in Healthy Adults: A Multicenter, Randomized, Double-blind, Parallel-group Pragmatic Clinical Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Iron Deficiency Anemia; Iron Deficiency
• Intervention / Treatment: Dietary supplement: Oral Sucrosomial iron; Dietary supplement: Oral Ferric maltol

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Mayo Hospital
    • Narowal, Punjab, Pakistan, 51600
      • DHQ Hospital Narowal
  • Sindh
    • Kotri, Sindh, Pakistan, 76000
      • Civil Hospital Kotri Distt Jamshoro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm 1; Subjects in this arm will receive an oral Sucrosomial 30mg elemental iron supplement, twice daily, for 6 weeks.	Dietary supplement: Oral Sucrosomial iron; 30 mg capsule
Active Comparator: Intervention Arm 2; Subjects in this arm will receive an oral Ferric maltol 30mg elemental iron supplement, twice daily, for 6 weeks.	Dietary supplement: Oral Ferric maltol; 30 mg capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the serum iron concentration	Increase in the circulatory iron levels	6 weeks
Changes in the serum ferritin concentration	Increase in the circulatory ferritin levels	6 weeks
Change in blood Hemoglobin (Hb) levels	Increase in the blood (Hb) levels	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Red Blood Cells	Increase in red blood cell counts	6 weeks
Change in blood Hemoglobin (Hb) levels	Increase in the blood (Hb) levels	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of gastrointestinal side effects	Incidence of treatment-emergent gastrointestinal side effects	6 weeks

Collaborators and Investigators

• Sponsor: Liaquat University of Medical & Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2023
• Primary Completion (Estimated): May 15, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Iron Metabolism Disorders; Anemia, Hypochromic; Iron Deficiencies; Anemia; Anemia, Iron-Deficiency; Hematinics; Ferric maltol
• Other Study ID Numbers: LUMHS/REC/-86

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No