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

Iron Deficiency Anemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05985070
• Other study ID #: LUMHS/REC/-86
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2024
• Source: Liaquat University of Medical & Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency
• Iron Deficiency Anemia

Intervention

Dietary Supplement:
• Oral Ferric pyrophosphate
30 mg capsule
• Oral Sodium ferric pyrophosphate
30 mg capsule
• Oral Ferric maltose
30 mg Tablet

Locations

Country	Name	City	State
Pakistan	Bilawal Medical College Hospital	Kotri	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Liaquat University of Medical & Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of gastrointestinal side effects	Incidence of treatment-emergent gastrointestinal side effects	6 weeks
Primary	Changes in the serum iron concentration	Increase in the circulatory iron levels	6 weeks
Primary	Changes in the serum ferritin concentration	Increase in the circulatory ferritin levels	6 weeks
Primary	Changes in the serum Total iron binding capacity (TIBC) concentration	Decrease in the circulatory TIBC levels	6 weeks
Secondary	Change in Red Blood Cells	Increase in red blood cell counts	6 weeks
Secondary	Change in blood Hemoglobin (Hb) levels	Increase in the blood (Hb) levels	6 weeks