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El ensayo clínico NCT06069856 (MIFA-ACT) para Relacionado con el embarazo está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Multiple Micronutrient Supplementation (MMS) vs IFA Acceptability Crossover Trial (MIFA-ACT) Fase III 130 Aleatorizado Diseño cruzado Etiqueta abierta

Aún no recluta
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El ensayo clínico NCT06069856 (MIFA-ACT) está diseñado para estudiar la prevención de Relacionado con el embarazo. Este es un estudio intervencionista de Fase III. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de mayo de 2026 hasta completar 130 participantes. Dirigido por la Universidad George Washington, se espera que finalice el 1 de diciembre de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 5 de febrero de 2026.
Resumen
This is an open-label individually randomized mixed methods cross-over trial to assess acceptability, preference, and side effects of IFA formulations with 60 mg of iron to MMS formulations with 60 mg of iron.
Título oficial

Individually Randomized Crossover Trial of Multiple Micronutrient Supplementation (MMS) Versus IFA During Pregnancy in Tanzania

Condiciones médicas
Relacionado con el embarazo
Otros ID del estudio
  • MIFA-ACT
Número del NCT
NCT06069856
Inicio del estudio (real)
2026-05-01
Última actualización
2026-02-05
Fecha de finalización (estimada)
2026-12
Inscripción (prevista)
130
Tipo de estudio
Intervencionista
FASE
Fase III
Estado general
Aún no recluta
Palabras clave
Acceptability
Multiple Micronutrient Supplementation
Iron
IFA
Tanzania
Objetivo principal
Prevención
Método de asignación
Aleatorizado
Modelo de intervención
Diseño cruzado
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalMMS with 60 mg of iron first, then IFA with 60 mg of iron
Women will receive the first regimen (MMS with 60 mg of iron) for 2 months and then crossover on to the second regimen (IFA with 60 mg of iron) for 2 months
Iron Folic Acid Tablets with 60 mg of iron
IFA with 60 mg iron is an intervention group. IFA with 60 mg of iron will be taken orally once daily from the time of randomization
Multiple Micronutrient Supplements with 60 mg of elemental iron
MMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization.
ExperimentalIFA with 60 mg of iron first, then MMS with 60 mg of iron
Women will receive the first regimen (IFA with 60 mg of iron) for 2 months and then crossover on to the second regimen (MMS with 60 mg of iron) for 2 months
Iron Folic Acid Tablets with 60 mg of iron
IFA with 60 mg iron is an intervention group. IFA with 60 mg of iron will be taken orally once daily from the time of randomization
Multiple Micronutrient Supplements with 60 mg of elemental iron
MMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization.
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Acceptability of formulation
To assess acceptability of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron using Likert scales ranging from 1 (disliked a lot) to 5 (liked a lot).
At two months of taking each regimen
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Most preferred formulation
To assess participated reported preference of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron by asking participants which supplement they like the best.
At four months (after taking both regimens)
Side Effects of formulation
To assess the percentage of patients experiencing side effects of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron
At two months of taking each regimen
Adherence
Percentage pill count of the number of supplements taken
At two months of taking each regimen
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Mujer
Admisión de voluntarios sanos
Sí
  • Attending first ANC visit at the study clinic
  • Pregnant women ≤ 15 weeks of gestation
  • Aged ≥ 18 years
  • Intending to stay in the study area for the duration of study
  • Provides informed consent

  • Severe anemia (defined as Hb <8.5 g/dL per Tanzania standard of care)
  • Sickle cell disease (SS,SC, CC genotype) as tested by HemoTypeSC
  • Concurrent participation in other nutritional supplementation trial
  • Pregnant women with disability or condition which would impair their ability to provide informed consent and complete study procedures.
George Washington University logoUniversidad George Washington
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Parte responsable del estudio
Emily Smith, Investigador principal, Principal Investigator, George Washington University
Contactos centrales del estudio
Contacto: Emily R Smith, ScD, MPH, 202-994-3589, [email protected]
Contacto: Christopher R Sudfeld, ScD, ScM, [email protected]
Sitio no especificado.