Health Condition 1: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
Intervention1: Intravenous ferric carboxymaltose (FCM): The intervention arm will receive intravenous ferric carboxymaltose (FCM), administered as a single dose of 15 mg/kg (up to a maximum of 1000 mg
however, a new dose may be given if the medication is spilled before ingestion. Caregivers will receive training on proper administration techniques and will maintain a daily treatment diary documenti
Sponsors
Dr Mounika Reddy
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 7 to 18 years with a confirmed diagnosis of severe iron deficiency anemia, based on hematological parameters Written informed consent obtained from parents or legal guardians along with assent from the child, as appropriate. Willing to complete the study procedures and follow-up visits as per protocol
Exclusion criteria
Exclusion criteria: 1. Anemia of non-iron deficiency etiology hemoglobinopathies, bone marrow failure, chronic disease, etc 2. Concomitant B12 - less than 200 pg/mL or folate deficiency - serum folate less than 4 ng/mL anemia 3. Chronic kidney disease or chronic liver disease 4. Documented or suspected conditions causing significant intestinal malabsorption e.g., untreated celiac disease, inflammatory bowel disease, chronic diarrhea, short bowel syndrome 5. Ongoing clinically significant blood loss requiring active medical or surgical intervention e.g. uncontrolled gastrointestinal bleeding, hematuria, or gynecological bleeding requiring treatment. Stable, chronic menorrhagia will be included. 6. Neurological conditions affecting feeding, swallowing, or compliance e.g., cerebral palsy with feeding difficulties 7. Receipt of therapeutic iron or blood transfusion in the past 4 weeks to avoid confounding effects on hemoglobin and iron status response. 8. Immediate indication for packed red blood cell transfusion 9. Known allergy or hypersensitivity to intravenous or oral iron preparations. 10. Participation in another clinical trial. 11. Known or suspected pregnancy 12. Known hepatitis B or C or HIV infection - due to ongoing chronic inflammation Presence of any medical condition deemed to interfere with participation or adherence to the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in peripheral blood hemoglobin (g/dL) concentration from baseline to 4 weeks post-enrolmentTimepoint: Baseline to 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in hemoglobin and ferritin at 2, 4, 8, and 12 weeksTimepoint: 2, 4, 8, 12 weeks;Proportion of participants with adverse events and SAEsTimepoint: Baseline to 12 weeks;Change in health-related quality of life and fatigue scores from baseline to 12 weeksTimepoint: Baseline & 12 weeks | — |
Countries
India
Contacts
Public ContactOnkar Laxman Daware
AIIMS BIBINAGAR
Outcome results
None listed