Health Condition 1: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
Intervention1: Ferric Ammonium Citrate: Ferric Ammonium Citrate 93.5 mg (equivalent to 20 mg of elemental iron per sachet)
Formulation: Sachet for oral administration
Control Intervention1: Not Applic
Sponsors
AFT Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female patients aged eighteen years and above with a diagnosis of iron deficiency anaemia on the screening day and who are willing to provide written informed consent or assent to participate in the study will be included. 2.Patients must be diagnosed with iron deficiency anaemia classified as mild to moderate or moderate to severe based on haemoglobin level and serum ferritin level. 3.Haemoglobin levels used to diagnose anaemia are defined as follows. For non pregnant women aged eighteen years and above, no anaemia is defined as haemoglobin twelve grams per decilitre or above, mild anaemia as eleven to eleven point nine grams per decilitre, moderate anaemia as eight to ten point nine grams per decilitre, and severe anaemia as less than eight grams per decilitre. 4.For men, no anaemia is defined as haemoglobin thirteen grams per decilitre or above, mild anaemia as eleven to twelve point nine grams per decilitre, moderate anaemia as eight to ten point nine grams per decilitre, and severe anaemia as less than eight grams per decilitre. 5.Mild to moderate iron deficiency anaemia is defined as serum ferritin less than thirty micrograms per litre, and moderate to severe iron deficiency anaemia is defined as serum ferritin less than fifteen micrograms per litre. 6.Patients must be willing and able to understand and comply with all protocol requirements, including attendance at all required study visits. 7.Female patients of childbearing potential must have a negative urine pregnancy test and should either follow abstinence or use contraceptive methods with a failure rate of less than one percent.
Exclusion criteria
Exclusion criteria: 1.Patients who have received any iron containing drugs during the last three months prior to screening will be excluded. 2. Patients with a history of erythropoietin drug administration will be excluded. 3. Patients with known hypersensitivity to iron therapy, including oral or intravenous administration, or to any component of the study drug will be excluded. 4. Patients who have received hormone therapy, including androgens or anabolic steroids, or drugs that inhibit blood formation within three months prior to the start of the study will be excluded. 5. Patients with a history of severe allergic reactions or drug intolerance will be excluded. 6. Patients with fructose intolerance, glucose galactose malabsorption syndrome, or sucrase isomaltase deficiency will be excluded. 7. Patients with a past history of failure of iron therapy for iron deficiency anaemia will be excluded. 8. Patients with disorders of heme metabolism, including sideroachrestic anaemia, lead anaemia, or thalassemia, will be excluded. 9. Patients with iron overload conditions, including hemochromatosis or hemosiderosis, will be excluded. 10. Patients with anaemia due to causes other than iron deficiency will be excluded, including those with haemolysis, vitamin B twelve or folic acid deficiency, chronic kidney disease with creatinine clearance below ninety millilitres per minute calculated using the Cockcroft Gault formula, or anaemia of chronic disease as per investigator judgement. 11. Patients with thyroid gland dysfunction, active inflammatory processes within ten days prior to screening, or elevated aspartate aminotransferase, alanine aminotransferase, or total bilirubin levels exceeding one point five times the upper limit of normal will be excluded. 12. Patients with clinically apparent hypothyroidism, in the opinion of the investigator, will be excluded. 13. Patients with malignant diseases, including blood or lymphoid tissue disorders such as leukaemia, Hodgkin disease, myelodysplastic syndrome, or myeloma, either at screening or in medical history with remission less than five years prior to screening, will be excluded. 14. Patients with signs or history of bone marrow aplasia will be excluded. 15. Patients requiring parenteral iron therapy due to impaired absorption, gastrointestinal pathology, requirement for rapid iron replenishment, continuous significant blood loss, or sickle cell anaemia will be excluded. 16. Patients with an active Helicobacter pylori infection will be excluded, although enrolment may be considered after completion of eradication therapy. 17. Patients with concomitant diseases or conditions that may pose a safety risk or interfere with safety data interpretation, including myocardial infarction or stroke within six months prior to screening, unstable angina, severe arrhythmia not controlled by medication, decompensated diabetes mellitus, or nephrological disorders, will be excluded. 18. Patients with any other clinically significant disease, at the discretion of the investigator, will be excluded. 19. Pregnant or lactating women, or women planning to become pregnant during the study, will be excluded. 20. The Principal Investigator will have the final discretion to exclude a patient based on out of range laboratory values, considering the overall clinical context.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in blood haemoglobin levelTimepoint: Baseline, Week 2, Week 4, Week 6, Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Serum FerritinTimepoint: Baseline, Week 2, Week 4, Week 6, Week 8;Change in Serum Iron and Transferrin SaturationTimepoint: Baseline, Week 2, Week 4, Week 6, Week 8;Improvement in Clinical Symptoms (defined by an increase in haemoglobin)Timepoint: Baseline, week 8 | — |
Countries
India
Contacts
Public ContactDr Pankaj Patil
Genecht Research Pvt. Ltd.
Outcome results
None listed