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

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ClinicalTrials.gov Identifier: NCT05985070
Recruitment Status : Recruiting
First Posted : August 14, 2023
Last Update Posted : April 24, 2024
Sponsor:
Information provided by (Responsible Party):
Nazia Mumtaz, Liaquat University of Medical & Health Sciences

Study Description
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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, 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.


Condition or disease Intervention/treatment Phase
Iron Deficiency Iron Deficiency Anemia Dietary Supplement: Oral Ferric pyrophosphate Dietary Supplement: Oral Sodium ferric pyrophosphate Dietary Supplement: Oral Ferric maltose Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 17, 2023
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : October 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron Sodium

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Changes in the serum iron concentration [ Time Frame: 6 weeks ]
    Increase in the circulatory iron levels

  2. Changes in the serum ferritin concentration [ Time Frame: 6 weeks ]
    Increase in the circulatory ferritin levels

  3. Changes in the serum Total iron binding capacity (TIBC) concentration [ Time Frame: 6 weeks ]
    Decrease in the circulatory TIBC levels


Secondary Outcome Measures :
  1. Change in Red Blood Cells [ Time Frame: 6 weeks ]
    Increase in red blood cell counts

  2. Change in blood Hemoglobin (Hb) levels [ Time Frame: 6 weeks ]
    Increase in the blood (Hb) levels


Other Outcome Measures:
  1. Incidence of gastrointestinal side effects [ Time Frame: 6 weeks ]
    Incidence of treatment-emergent gastrointestinal side effects


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05985070


Locations
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Pakistan
Bilawal Medical College Hospital Recruiting
Kotri, Sindh, Pakistan, 76000
Contact: Nazia Mumtaz, M.B.B.S, F.C.P.S    03453001262    Drnaziahafeez@gmail.com   
Sponsors and Collaborators
Liaquat University of Medical & Health Sciences
More Information
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Responsible Party: Nazia Mumtaz, Assistant Professor Pathology, Liaquat University of Medical & Health Sciences
ClinicalTrials.gov Identifier: NCT05985070    
Other Study ID Numbers: LUMHS/REC/-86
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: April 24, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Iron Deficiencies
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
 Anemia, Hypochromic
Iron
Trace Elements
Micronutrients
Physiological Effects of Drugs