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

Not Applicable

Active, not recruiting

• Conditions: Iron Deficiency Anemia; Iron Deficiency
• Interventions: Dietary Supplement: Oral Ferric maltose; Dietary Supplement: Oral Ferric pyrophosphate; Dietary Supplement: Oral Sodium ferric pyrophosphate

• Registration Number: NCT05985070
• Lead Sponsor: Liaquat University of Medical & Health Sciences

Brief Summary

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.

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 Timeline

• Study Start: 2023-07-17
• Study First Submitted: 2023-08-02
• Study First Submitted QC: 2023-08-02
• Study First Posted: 2023-08-14
• Status Verified: 2024-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16
• Primary Completion: 2025-05-15
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional Arm 3	Oral Ferric maltose	Subjects in this arm will receive an oral 30mg elemental iron supplement as Ferric maltose, twice daily, for 6 weeks.
Intervention Arm 1	Oral Ferric pyrophosphate	Subjects in this arm will receive an oral 30mg elemental iron supplement as Ferric pyrophate, twice daily, for 6 weeks.
Intervention Arm 2	Oral Sodium ferric pyrophosphate	Subjects in this arm will receive an oral 30mg elemental iron supplement as Sodium Ferric pyrophate, twice daily, for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Changes in the serum iron concentration	6 weeks	Increase in the circulatory iron levels
Changes in the serum ferritin concentration	6 weeks	Increase in the circulatory ferritin levels
Change in blood Hemoglobin (Hb) levels	6 weeks	Increase in the blood (Hb) levels

Trial Locations

Locations (3)

Mayo Hospital; 🇵🇰 Lahore, Punjab, Pakistan

DHQ Hospital Narowal; 🇵🇰 Narowal, Punjab, Pakistan

Civil Hospital Kotri Distt Jamshoro; 🇵🇰 Kotri, Sindh, Pakistan