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A Study of iron sucrose and ferric carboxymaltose injections in patients with sickle cell disease and iron deficiency

Comparative Evaluation of Efficacy and Safety of Intravenous Iron Sucrose versus Ferric Carboxymaltose in Iron-Deficient Sickle Cell Disease Patients from a Tribal Tertiary Care Hospital of Gujarat: A Prospective Observational Cohort Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/06/112762
Enrollment
50
Registered
2026-06-15
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D571- Sickle-cell disease without crisis

Interventions

Intervention1: Nil: Nil

Sponsors

Rajdipkumar Naranbhai Garval
Lead Sponsor

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

MeasureTime 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

MeasureTime frame
Timepoint:

Countries

India

Contacts

Public ContactDrRajdipkumar Naranbhai Garval

zydus medical college and hospital

drvijaymd@gmail.com9944293895

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026