- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01093989
Acute vs. Delayed Iron Therapy: Effect on Iron Status, Anemia and Cognition
The research questions to be answered by this study are:
- Is treatment with iron more effective at improving anemia if given at the time of a malaria episode or 1 month after the episode?
- Which treatment timing is associated with more malaria episodes - 1 month delayed treatment or immediate treatment at the time of malaria?
- Does timing of iron treatment affect later thinking processes and behavior?
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study population in this study will be children who are enrolled in our ongoing study of cerebral malaria and severe malarial anemia, "Pathogenesis of cognitive/neurologic deficits in central nervous system malaria", underway in Kampala, Uganda. The pathogenesis study seeks to address the question of why children with severe malaria have later problems in thinking. The study we are now proposing will build on this study by assessing whether children with severe malaria have iron deficiency, and if they do, whether treatment with iron at the time of malaria is less effective than treatment one month later. We believe that treatment one month later may be more effective because there is data that shows that the inflammation that occurs with a malaria episode may decrease the body's ability to absorb iron in the gut and to send iron to the places it is needed, like the bone marrow and the brain. We are doing this study to see if our hypothesis about more effective iron treatment if it is delayed is correct and assessing anemia prevalence, iron status, and long-term neurobehavioral development as outcomes.
We have three study groups: children with cerebral malaria, children with severe malarial anemia, and healthy community control children. Children found to be iron deficient will be randomized to receive iron (as ferrous sulphate syrup) either immediately or at their one-month follow-up visit. At 1-, 6, and 12-month follow-up visits changes in iron and inflammation indicators will be assessed. At the 6- and 12-month visits, neurocognitive behavior will also be evaluated and compared between the immediate vs. delayed iron groups. Malaria morbidity will be assessed via home visits during the period of iron supplementation and via clinic monitoring for the duration of the study.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kampala, Uganda
- Mulago Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
All children must
- Be between the ages of 18 mo and 5 y
- Reside within 20 km of study hospital
Children with cerebral malaria must have
- Coma (BCS < 3)
- P. falciparum on blood smear
- No clinical evidence or other causes of encephalopathy
Children with severe malarial anemia must have
- Hemoglobin < 5 g/dL
- Clinical symptoms of malaria
- P. falciparum on blood smear
Community control children must
- Live in same neighborhood or extended household as a child with severe malaria
- Be within one year of age as a child with severe malaria
Exclusion Criteria:
Cerebral malaria
- WBC > 10
- Positive gram stain or culture
Severe malarial anemia
- Impaired conscious on physical exam
- Seizure activity prior to or during physical exam
- Any other evidence of CNS disease
- All exclusion criteria of CM except no lumbar puncture required
Community control children
- All exclusion criteria for CM
- Any active illness, recent illness, or recovery from illness
- Chronic illness requiring medical care
- Medical abnormalities on screening history of physical exam
- CC control with a positive malaria smear will be treated but will not be excluded from the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: Immediate iron
Iron-deficient children will be randomized to receive iron concurrently with anti-malarial treatment or one month later (delayed iron group).
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Iron therapy will consist of a three-month course of ferrous sulphate syrup.
For children with Hb ≥ 7 g/dL, each daily dose will be based on 2 mg iron/kg body weight.
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Comparador activo: Delayed iron
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Iron therapy will consist of a three-month course of ferrous sulphate syrup.
For children with Hb ≥ 7 g/dL, each daily dose will be based on 2 mg iron/kg body weight.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Hemoglobin change, anemia prevalence, and socioemotional behavior in the immediate iron vs. delayed iron groups
Periodo de tiempo: 6 months
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6 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Chandy C John, M.D., University of Minnesota
Publicaciones y enlaces útiles
Publicaciones Generales
- Blatt DB, Hanisch B, Co K, Datta D, Bond C, Opoka RO, Cusick SE, Michelow IC, John CC. Impact of Oxidative Stress on Risk of Death and Readmission in African Children With Severe Malaria: A Prospective Observational Study. J Infect Dis. 2022 Sep 4;226(4):714-722. doi: 10.1093/infdis/jiac234.
- Cusick SE, Opoka RO, Ssemata AS, Georgieff MK, John CC. Delayed iron improves iron status without altering malaria risk in severe malarial anemia. Am J Clin Nutr. 2020 May 1;111(5):1059-1067. doi: 10.1093/ajcn/nqaa004.
- Cusick SE, Opoka RO, Ssemata AS, Georgieff MK, John CC. Comparison of iron status 28 d after provision of antimalarial treatment with iron therapy compared with antimalarial treatment alone in Ugandan children with severe malaria. Am J Clin Nutr. 2016 Mar;103(3):919-25. doi: 10.3945/ajcn.115.117820. Epub 2016 Feb 3.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 0909M72852
- 1U01HD064698-01 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Ferrous Sulphate Syrup
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King's College LondonDesconocidoTrastornos del metabolismo de la glucosa | Comportamiento apetitivoReino Unido
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Swiss Federal Institute of TechnologyJomo Kenyatta University of Agriculture and TechnologyTerminadoDeficiencia de hierro | La anemia por deficiencia de hierro | Hemorragia gastrointestinalKenia
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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
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Boehringer IngelheimTerminadoDermatitis Atópica