Health Condition 1: D509- Iron deficiency anemia, unspecified Health Condition 2: D508- Other iron deficiency anemias
Conditions
Interventions
Intervention1: Ferric pyrophosphate, Micronised encapsulated (MEFP): Oral tablet containing elemental iron 30mg
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Sponsors
ALS
Eligibility
Inclusion criteria
Inclusion criteria: 1 Moderate iron deficiency anemia (Hb 8.0 -10.0 gm/dl) undergone at least one cycle of chemotherapy or radiation under the supervision of an Oncologist 2 Age between 18 and 70 years
Exclusion criteria
Exclusion criteria: 1 Patients taking any iron supplement at the time of enrolment 2 History of previous blood transfusion in the last 06 months 3 Patients with Haemolytic anemia, Haemoglobinopathies, Myelodysplastic Syndromes and other blood disorders. 4 Gastrointestinal surgeries that may impair iron absorption 5 Patients with severe anemia (less than 8 gm/dl) require parenteral iron and/or blood transfusion. 6 Patients with serious cardiac, respiratory, neurological, gastrointestinal disease may not fit the study protocol in the opinion of the investigator. 7 Female subjects demonstrating a positive pregnancy test 8 Any patient diagnosed with severe gastritis, peptic ulcer, GI bleed or any other causes of pathological bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Hb level, MCV, MCH, MCHC and RDW from baseline to end of treatment Change in the Transferrin Saturation and Serum Ferritin from baseline to end of treatmentTimepoint: Change in the Hb level, MCV, MCH, MCHC and RDW from baseline to end of treatment Change in the Transferrin Saturation and Serum Ferritin from baseline to end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| AE either spontaneously reported by the patient or notified by the Physician during the trialTimepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactDr Arya
ALS
Outcome results
None listed