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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05985070
Other study ID # LUMHS/REC/-86
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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