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
Verified date | April 2024 |
Source | Liaquat University of Medical & Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Bilawal Medical College Hospital | Kotri | Sindh |
Lead Sponsor | Collaborator |
---|---|
Liaquat University of Medical & Health Sciences |
Pakistan,
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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