Daily Versus Alternate-Day Oral Iron Therapy for Anemia in Second-Trimester Pregnancy
Daily Versus Alternate-Day Oral Iron Therapy for Anemia Correction in Second-Trimester Pregnant Patients: A Randomized Controlled Trial
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Iron deficiency anemia is the leading cause of anemia in pregnancy. Although daily oral iron is standard first-line therapy, it is frequently associated with gastrointestinal side effects and poor adherence. Because hepcidin rises after an iron dose and remains elevated for 24 to 48 hours, daily dosing may reduce fractional absorption; alternate-day dosing allows hepcidin to fall between doses, potentially improving absorption and tolerance.
This single-center, prospective, randomized, parallel-group trial will recruit pregnant women (13 to 27 weeks gestation) with hemoglobin below 11 g/dL and serum ferritin below 30 ng/mL from the antenatal clinic at PAF Teaching Hospital, Islamabad. Eligible, consenting participants will be randomized 1:1 to daily ferrous sulfate (one 325 mg tablet, approximately 65 mg elemental iron, once daily) or alternate-day ferrous sulfate (two 325 mg tablets, approximately 130 mg elemental iron, every other day) for four weeks.
The primary outcome is change in hemoglobin from baseline to Week 4. Secondary outcomes are change in serum ferritin, treatment adherence (proportion taking at least 80 percent of doses, by pill count and diary), and the frequency and severity of gastrointestinal side effects. Outcome assessors (laboratory personnel) are blinded to allocation; participant blinding is not feasible given the differing dosing schedules. Planned enrollment is 184 participants (92 per group), giving 90 percent power to detect a 0.40 g/dL difference in hemoglobin change at a two-sided alpha of 0.05, assuming a standard deviation of 0.83 g/dL.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ammara Suleman
- Número de teléfono: +92 321 5279502
- Correo electrónico: shazibnawaz2016@gmail.com
Ubicaciones de estudio
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Islamabad, Pakistán
- Pakistan Air Force (PAF) Hospital Islamabad
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Aged 18 to 40 years
- Pregnant women in the second trimester (13 to 27 weeks gestation)
- Hemoglobin below 11 g/dL with serum ferritin below 30 ng/mL
- Singleton pregnancy
Exclusion Criteria:
- Known congenital or acquired hemoglobin disorders (e.g., thalassemia, hemoglobinopathies)
- Chronic diseases affecting hemoglobin levels (e.g., chronic kidney disease, inflammatory disorders)
- Bleeding disorders or a history of frequent blood loss
- Gastrointestinal conditions impairing nutrient absorption (e.g., celiac disease or other malabsorption syndromes)
- Currently receiving parenteral iron
- Requiring blood transfusion
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Daily Iron
One ferrous sulfate 325 mg tablet (approximately 65 mg elemental iron) once daily for four weeks.
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Oral ferrous sulfate 325 mg tablets (approximately 65 mg elemental iron per tablet) administered for four weeks according to the assigned dosing schedule.
All participants receive standardized counseling on administration, diet, side effects, and adherence, and are issued a dose diary.
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Experimental: Alternate-Day Iron
Two ferrous sulfate 325 mg tablets (approximately 130 mg elemental iron) every other day for four weeks.
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Oral ferrous sulfate 325 mg tablets (approximately 65 mg elemental iron per tablet) administered for four weeks according to the assigned dosing schedule.
All participants receive standardized counseling on administration, diet, side effects, and adherence, and are issued a dose diary.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in hemoglobin from baseline to Week 4
Periodo de tiempo: Baseline and Week 4
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Mean within-participant change in hemoglobin concentration (g/dL), measured at baseline and at Week 4, compared between the daily and alternate-day arms.
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Baseline and Week 4
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in serum ferritin from baseline to Week 4
Periodo de tiempo: Baseline and Week 4
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Mean within-participant change in serum ferritin concentration (ng/mL) from baseline to Week 4, compared between groups.
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Baseline and Week 4
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Treatment adherence
Periodo de tiempo: Through Week 4
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Proportion of participants taking at least 80 percent of prescribed doses, determined by pill count cross-checked against patient dose diaries.
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Through Week 4
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Frequency of gastrointestinal side effects
Periodo de tiempo: Through Week 4
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Proportion of participants reporting any gastrointestinal side effect (nausea, vomiting, constipation, metallic taste, or abdominal discomfort) recorded using a structured checklist.
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Through Week 4
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Severity of gastrointestinal side effects
Periodo de tiempo: Through Week 4
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Severity of reported gastrointestinal side effects graded as mild, moderate, or severe on a structured checklist.
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Through Week 4
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ammara Suleman, MBBS, Pakistan Air Force (PAF) Hospital Islamabad
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- IRON-DvA-2026-01
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.
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Ensayos clínicos sobre Ferrous Sulfate
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Ain Shams UniversityTerminadoLa lactoferrina con gluconato ferroso es más superior que el gluconato ferroso solo en el tratamiento de la anemia por deficiencia de hierroEgipto