Health Condition 1: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
Intervention1: Iron (III) Hydroxide Polymaltose 100mg Hard Gelatin Capsules: once daily for 12 weeks
Control Intervention1: Maltofer 370 mg Tablets (100mg iron as iron polymaltose): once daily for 12
Sponsors
AFT Pharmaceutical
Eligibility
Inclusion criteria
Inclusion criteria: - Adult male patients, non-pregnant female patients aged 18 years and above with a diagnosis of iron deficiency anaemia on the screening day and willing to provide written informed consent form to participate in the study. - Diagnosed iron deficiency anaemia based on 2 criteria: a.Haemoglobin level below 110 g per L but should be above 60 g per L. b.Serum ferritin level below 30 micro g per L. Patients must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits. Non-pregnant females and males diagnosed with iron deficiency anaemia are eligible. Female patients of childbearing potential must have a negative urine pregnancy per Beta-hCG results and should follow abstinence or use contraceptive methods with a failure rate of less than 1 percent
Exclusion criteria
Exclusion criteria: Administration of any iron-containing drugs during the last3 months. - History of erythropoietin drug administration. - Hypersensitivity to iron therapy both Oral and or IV administration and other components of the study drugs. - Hormone therapy including the use of androgens or 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. -Fructose intolerance, glucose-galactose malabsorption syndrome, and sucrase isomaltase deficiency. - Failure of iron therapy for iron-deficiency anaemia in a patients past medical history. - Heme metabolism disorders eg sideroachrestic anaemia, lead anaemia, thalassemia. - Iron overload including hemochromatosis and hemosiderosis. - Other causes of anaemia, apart from iron deficiency, including - Haemolysis determined as per analysis results at screening, or as per anamnestic data. - Vitamin B12 and folic acid deficiency as per the screening data. - Chronic kidney disease creatinine clearance at screening is below 90 ml per min based on Cockcroft Gault Formula. - Systemic connective tissue diseases, chronic infectious diseases requiring regular therapy as per the past medical history, and other conditions which may, in the investigators opinion, be accompanied by anaemia of chronic diseases. Dysfunction of the thyroid gland based on the data obtained at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in blood haemoglobin levelTimepoint: Baseline and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum ironTimepoint: baseline, weeks 4,week 8 and week 12;Change in TransferrinTimepoint: Baseline, week 4, week 8 and week 12;Change in Percent Transferrin saturationTimepoint: Baseline, week 4, week 8 and week 12;Change in ferritinTimepoint: Baseline, week 4, week 8 and week12;Number of patients with a response to the therapyTimepoint: Baseline and week 12 | — |
Countries
India
Contacts
Public ContactDr Pankaj Patil
Genecht Research Pvt. Ltd.
Outcome results
None listed