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

Evaluating the Effectiveness of Various Iron Salts and Carrier Systems in Oral Iron Therapy for Iron Deficiency and Anemia in Healthy Adults: A Randomized, Double-blind, Parallel-group 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, ferrous gluconate, ferrous fumarate, ferric maltose and ferric pyrophosphate. Each salt differs in elemental iron content and potential side effects, allowing for tailored treatment based on individual patient needs and tolerability.

Moreover, 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: Recruiting
• Conditions: Iron Deficiency Anemia; Iron Deficiency
• Intervention / Treatment: Dietary supplement: Oral Ferric pyrophosphate; Dietary supplement: Oral Sodium ferric pyrophosphate; Dietary supplement: Oral Ferric maltose

Detailed Description

The current randomized, parallel-group, clinical trial study aims to conduct a comparative analysis of the effectiveness of three different oral iron formulations: ferric maltose, ferric pyrophosphate, and sodium ferric pyrophosphate. Each of these formulations is delivered in a distinct carrier system. 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. By assessing various iron salts and carrier systems, the research aims to provide valuable insights into which formulation offers the most effective and well-tolerated treatment option for patients with iron deficiency or iron deficiency anemia. 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 (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Kotri, Sindh, Pakistan, 76000
      • Recruiting
      • Bilawal Medical College Hospital
      • Contact: Nazia Mumtaz, M.B.B.S, F.C.P.S; Phone Number: 03453001262; Email: Drnaziahafeez@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Outpatients
• Age: 18 - 45 years, both gender
• Haemoglobin level < 12 g/dL
• Serum ferritin levels < 30 µg/L.
• Transferrin Saturation (TSAT) < 20 %
• Able to provide informed written consent.
• Able to adhere to the study protocol and willing to cooperate with the study investigators.

Exclusion Criteria:

• Other causes of anaemia, apart from iron deficiency.
• Pregnant or lactating women, or women intending to become pregnant during the study.
• Administration of any iron-containing drugs during the last 3 months.
• History of erythropoietin drugs administration.
• People with cancer, chronic liver disease, chronic kidney disease, HIV, cardiovascular disease, pulmonary disease, mental health disorder, inflammatory disease such as IBD, any GI disease or disorder likely to affect the nutritional intestinal absorption.
• Subjects on Antacids (aluminium, calcium, magnesium preparations), anti-inflammatory drugs (NSAIDs, salicylates), antibiotic medications (aminoglycosides), cholesterol lowering medication (Bile acid-sequestrants), Ulcer medication (histamine H2 Antagonists), PPIs etc.
• Concomitant diseases and conditions, which, in the investigator's opinion, pose risk to a subject's safety in case of his/her participation in the study, or able to affect the safety data analysis in case of exacerbation of this disease/condition during the study.
• Hypersensitivity to iron therapy (both Oral and/or IV administration) and other components of the study drugs.
• Hormone therapy (including the use of androgens/anabolic steroids) or administration of drugs that inhibit blood formation, less than 3 months before the start of the study.
• History of severe allergic reactions or drug intolerance.
• Blood donation / blood transfusion within 30 days prior to screening or planned blood transfusion at time of screening.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm 1; Subjects in this arm will receive an oral 30mg elemental iron supplement as Ferric pyrophate, twice daily, for 6 weeks.	Dietary supplement: Oral Ferric pyrophosphate; 30 mg capsule
Experimental: Intervention Arm 2; Subjects in this arm will receive an oral 30mg elemental iron supplement as Sodium Ferric pyrophate, twice daily, for 6 weeks.	Dietary supplement: Oral Sodium ferric pyrophosphate; 30 mg capsule
Active Comparator: Interventional Arm 3; Subjects in this arm will receive an oral 30mg elemental iron supplement as Ferric maltose, twice daily, for 6 weeks.	Dietary supplement: Oral Ferric maltose; 30 mg Tablet

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
Changes in the serum Total iron binding capacity (TIBC) concentration	Decrease in the circulatory TIBC 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): August 31, 2024
• Study Completion (Estimated): October 31, 2024

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 24, 2024
• Last Update Submitted That Met QC Criteria: April 20, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia; Iron Deficiencies; Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• 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