Comparative Analysis of Oral Iron With Injectable Ferric Carboxymaltose for Post Partum Iron Deficiency Anaemia
Comparative Analysis of Oral Iron With Injectable Ferric Carboxymaltose for Treatment of Post Partum Iron Deficiency Anaemia
The aim of this open label, interventional, randomized controlled clinical trial is to compare the efficacy and safety of ferric carboxymaltose injection with oral iron in treatment of postpartum iron deficiency anaemia in postnatal women. Inclusion criteria:women within 10 days of delivery, Hb >7 gm/dl and ≤10 gm and peripheral smear showing microcytic hypochromic anaemia or red cell indices suggestive of iron deficiency anaemia or Mentzer index >13.
Primary outcome measures-rise in Hb from baseline to 4 and 6 weeks Secondary outcome measures-Percentage of patients achieving Hb >11 g/dl at 4 and 6 weeks.
Percentage of patients achieving Hb rise >3 g/dl from baseline at 4 and 6 weeks Change in red cell indices and peripheral smear from baseline to 6 weeks Side effects profile of injectable Ferric carboxymaltose injection and oral iron.
Researcher compares the efficacy and safety of ferric carboxymaltose with Oral iron in post partum iron deficiency anaemia Participant's detailed history, general physical and systemic examination was performed. CBC with red cell indices, reticulocyte counts, peripheral smear examination, serum Iron, Ferritin, Transferrin, TIBC levels and LFT were done.
Subjects were randomized in a 1:1 ratio into two groups: Group I (n=100) received intravenous ferric carboxymaltose and Group II (n=100) received oral ferrous Fumarate twice a day for 6 weeks.
All subjects were followed at 4 and 6 weeks. Repeat Hb estimation was done at 4 and 6 weeks while RBC indices and serum iron parameters were repeated at 6 weeks. Adverse effects were recorded.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Delhi, India, 110015
- ESI-PGIMSR, Basaidarapur
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Postnatal women within 10 days of delivery.
- Hb should be >7 gm/dl and ≤10 gm.
- Peripheral smear showing microcytic hypochromic anaemia or red cell indices suggestive of iron deficiency anaemia or Mentzer index >13.
Exclusion Criteria:
- 1. Puerperal pyrexia. 2. Known drug allergy or intolerance to iron therapy. 3. History of chronic medical illness. 4. Known cases of Thalassemia 5. Received other intervention for management of anaemia such as blood transfusion in last three months.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Group I: Ferric carboxymaltose (FCM)
FCM was given as slow intravenous infusion; maximum single dose not exceeding 15 mg/kg or 1000 mg/dose in 250 ml of 0.9% normal saline over 15 minutes During infusion, subject was kept under strict observation. FCM was repeated weekly up to calculated dose or maximum of 2500mg. Total dose of IV FCM was calculated by Ganzoni formula: - Total dose of iron = body weight (in kg) x (14-actual Hb) x 2.4 + 500 where, 14 is target Hb (g/dl), 2.4 unitless conversion constant, 500 is target iron store in mg |
FCM was given as slow intravenous infusion; maximum single dose not exceeding 15 mg/kg or 1000 mg/dose in 250 ml of 0.9% normal saline over 15 minutes.
FCM was repeated weekly up to calculated dose or maximum of 2500mg.
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Comparador activo: Group II : Oral Iron
Second group of subjects were instructed to take oral iron (ferrous fumarate tablet containing 112 mg elemental iron) 2 times daily 1 hour before meals for 6 weeks.
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FCM was given as slow intravenous infusion; maximum single dose not exceeding 15 mg/kg or 1000 mg/dose in 250 ml of 0.9% normal saline over 15 minutes.
FCM was repeated weekly up to calculated dose or maximum of 2500mg.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mean increase in haemoglobin at 4 weeks and 6 weeks in Group I versus Group II
Periodo de tiempo: Haemoglobin measurement at baseline, 4 week post treatment and 6 week post FCM intervention or adequate oral treatment
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The mean change in haemoglobin was measured at 4 weeks and 6 weeks post intervention in parenteral and oral group.
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Haemoglobin measurement at baseline, 4 week post treatment and 6 week post FCM intervention or adequate oral treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Anaemia correction(Hb >11 gm/dl), from baseline at 4 and 6 weeks in group I versus Group II
Periodo de tiempo: Anaemia correction (Hb>11gm/dl) at 4 week and 6 week post FCM intervention or adequate oral treatment
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Percentage of women in the parenteral group as compared to oral group who achieved correction of anaemia i.e.
Hb >11gm/dl at 4 and 6 weeks post intervention.
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Anaemia correction (Hb>11gm/dl) at 4 week and 6 week post FCM intervention or adequate oral treatment
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Haemoglobin (Hb) rise> 3gm/dl from baseline at 4 and 6 weeks in group I versus Group II
Periodo de tiempo: Hb rise> 3 gm/dl at 4 week and 6 week post FCM intervention or adequate oral treatment
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Women in the parenteral group as compared to oral group who achieved Haemoglobin rise of >3gm/dl at 4 and 6 weeks post intervention.
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Hb rise> 3 gm/dl at 4 week and 6 week post FCM intervention or adequate oral treatment
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Haemoglobin (Hb) rise>2gm from baseline at 4 and 6 weeks in group I versus Group II
Periodo de tiempo: Hb rise>2gm/dl at 4 week and 6 week post FCM intervention or adequate oral treatment
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Women in the parenteral group as compared to oral group who achieved haemoglobin (Hb) rise>2gm from baseline at 4 week and 6 week post intervention.
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Hb rise>2gm/dl at 4 week and 6 week post FCM intervention or adequate oral treatment
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Change in red cell indices and peripheral smear from baseline to 6 weeks
Periodo de tiempo: Change in red cell indices and peripheral smear at baseline and 6 week post FCM intervention or adequate oral treatment
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To record changes in all the haematological parameters from baseline to 6 weeks post intervention both parenteral and oral groups.
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Change in red cell indices and peripheral smear at baseline and 6 week post FCM intervention or adequate oral treatment
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Side effects profile for participants of Group I and II
Periodo de tiempo: Side effects observed in participants receiving Group I and Group II treatment upto 6 weeks post intervention..
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To record the side effect profile in participants of parenteral and oral group in order to determine safety of the intervention upto 6 weeks post intervention.
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Side effects observed in participants receiving Group I and Group II treatment upto 6 weeks post intervention..
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Shreya Mahajan, MBBS, Post graduate resident, Department of OBG, ESI-PGIMSR, Basaidarapur,Delhi
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ESIPGIMSR-IEC/2024031
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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