Health Condition 1: D571- Sickle-cell disease without crisis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Willing and able to provide written informed consent or assent with guardian consent for minors Confirmed diagnosis of Sickle Cell Disease (Hbss type Age 5 years and above Documented iron deficiency: Serum Ferritin less then 30 ngpermL and or TSAT less then 20 percent with or without low MCVandMCH Hemoglobin more then or equal to 5 gperdL and less then or equal to 10 gperdL at baseline Not on regular blood transfusion therapy less then or equal 1 in the past 3 months
Exclusion criteria
Exclusion criteria: Patients on regular transfusion therapy more than once in the past 3 months Serum ferritin more then 200 ngpermL iron overload or equivocal iron status Known hypersensitivity to iron sucrose or ferric Carboxymaltose Deranged liver function ALTorAST beyond double upper limit of normal Deranged Renal function Serum creatinine more then 2mgperdl Significant active infection requiring IV antibiotics at time of enrolment Other identifiable causes of anemia severe vitamin B12orfolate deficiency thalassemia co inheritance Patients who received IV iron within the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ferric Carboxymaltose may perform comparably or better than Iron Sucrose in correcting iron deficiency in Sickle Cell Disease patientsTimepoint: Greater rise in Hemoglobin (Hb), serum ferritin, and TSAT at weeks 4, 12, and 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint: | — |
Countries
India
Contacts
zydus medical college and hospital