E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Iron deficiency anemia |
anemia ferropénica |
|
E.1.1.1 | Medical condition in easily understood language |
Iron deficiency anemia, a condition in which blood lacks adequate number of red blood cells due to insufficient iron |
anemia ferropénica que es debida a una disminución en el número de glóbulos rojos en la sangre por falta de hierro |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluate the efficacy of a liposome iron food supplement in the treatment of iron deficiency anemia in pregnant women, compared with the standard: ferrous sulfate |
Evaluar la eficacia de un complemento alimenticio de hierro liposomado en el tratamiento de la anemia ferropénica en la gestante, comparado con el estándar: sulfato ferroso |
|
E.2.2 | Secondary objectives of the trial |
Evaluate the secondary effects of the treatment with liposome iron and ferrous sulphate and the rate of abandonment due to intolerance.
Evaluate the kinetics of iron in the newborn via a sample obtained from blood cord and for the study of ferritin, transferrin and transferrin saturation index |
Evaluar los efectos secundarios del tratamiento con hierro liposomado y sulfato ferroso y la tasa de abandono del mismo por intolerancia.
Evaluar la cinética del hierro en el recién nacido mediante muestra obtenida de sangre de cordón para estudio de ferritina, transferrina e indice de saturación de la transferrina |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Age over 18 years. -Pregnancy with a single fetus. -Figures of hemoglobin, ferritin, transferrin and transferrin saturation index described in the selection of subjects. -Have completed a basic study on the etiology of anemia. -Known gestational age. -Acceptance of participating in the study and signing of informed consent. -Intake of folic acid, vitamin B12 or iodine with the recommendation / supplementation standards existing in pregnancy |
-Edad superior a 18 años. -Embarazo con feto único. -Cifras de hemoglobina, ferritina, transferrina e índice de saturación de la transferrina descritas en la selección de sujetos. -Haber cumplimentado un estudio básico sobre la etiología de la anemia. -Edad gestacional conocida. -Aceptación de participar en el estudio y firma del consentimiento informado. -Ingesta de ácido fólico, vitamina B12 o yodo con los estándares de recomendación/suplementación existentes en el embarazo. |
|
E.4 | Principal exclusion criteria |
Presence of intercurrent haematological diseases (haemosiderosis, hemochromatosis, sideroblastic or sideracestic anemias, thalassemia) or of another nature. Previous blood transfusion in the month prior to inclusion in the study. Intake of polyvitamins containing iron. Patient who is suspected of low predictable compliance. Patients with poor adherence to the treatment objectified as described in the therapeutic compliance section. Obstetric or medical-surgical situations involving blood loss (eg, placenta previa, bleeding gastric ulcer, hemorrhoids). Kidney chronic disease Diseases known to cause specific difficulty for the absorption of iron orally (eg some types of bariatric surgery). Interruption of pregnancy for whatever reason two months after initiating the protocol. Severe iron deficiency anemia or anemia with hemoglobin in the inclusion range but with poor clinical tolerance, which makes them parenteral iron tributaries. Iron allergy Contraindication to folic acid or vitamin B12 |
Presencia de enfermedades hematológicas intercurrentes (hemosiderosis, hemocromatosis, anemias sideroblásticas o sideraocrésticas, talasemia) o de otra naturaleza. Transfusión previa de sangre en el mes anterior a la inclusión en el estudio. Ingesta de polivitamínicos que contengan hierro. Paciente de quien se sospeche un bajo cumplimiento predecible. Pacientes con mala adherencia al tratamiento objetivado según lo descrito en el apartado de cumplimiento terapéutico. Situaciones obstétricas o médico-quirúrgicas que comporten pérdida de sangre (p.ej. placenta previa, ulcus gástrico sangrante, hemorroides). Insuficiencia renal crónica Enfermedades que se conoce comportan dificultad específica para la absorción del hierro por vía oral (p.ej. algunos tipos de cirugía bariátrica). Interrupción del embarazo por el motivo que sea antes de dos meses de iniciar el protocolo. Anemias ferropénicas severas o anemias con hemoglobina en rango de inclusión pero que presentan mala tolerancia clínica, lo que las haga tributarias de hierro parenteral. Alergia al hierro. Contraindicación al ácido fólico o vitamina B12. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Evolution of hemoglobin levels throughout the treatment. A record of the recovery of Hb levels at the end of the study will be made, considering as a positive response: -Patients who do not suffer from anemia at the end of pregnancy. -Increase of at least 1g / dl at 12 weeks compared to baseline |
Evolución de los niveles de hemoglobina a lo largo del tratamiento. Se realizará un registro de la recuperación de los niveles de Hb al final del estudio, considerándose como respuesta positiva: -Pacientes que no padecen anemia a término del embarazo. -Incremento de al menos 1g/dl a las 12 semanas respecto al valor basal |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
First Quarter Selection visit: Week 12 2nd visit: Week 16-17 3rd visit: Week 24-26 4th visit: Week 30 5th visit: Week 34-36 6th visit: Pre labour Post Labour visit: Week 2-3 puerperium
Second quarter Selection visit: Week 24 Second visit: Week 29-30 Third visit: Week 34-36 Post Labour visit: Week 2-3 puerperium |
Primer trimestre Visita de selección: Semana 12 2ª visita: Semana 16-17 3ª visita: Semana 24-26 4ª visita: Semana 30 5ª visita: Semana 34-36 6ª visita: Preparto Visita postparto: Semana 2-3 puerperio
Segundo trimestre Visita de Selección: Semana 24 Segunda visita:Semana 29-30 Tercera visita: Semana 34-36 Visita postparto: Semana 2-3 puerperio |
|
E.5.2 | Secondary end point(s) |
- Analytical parameters: ferritin, transferrin, transferrin saturation index. Laboratory evaluations will collect complete blood count and iron kinetics data.
-Side effects in each treatment group. The tolerability that patients present to treatment will be evaluated; for this, a questionnaire will be carried out in which the general welfare of the patient as well as different gastrointestinal symptomatology will be collected The appearance of gastrointestinal symptoms such as: Sickness Vomiting Epigastralgia Change in stool color Constipation |
-Parámetros analíticos: ferritina, transferrina, transferrin saturation index. Las evaluaciones de laboratorio recogerán hemograma completo y datos de cinética de hierro.
-Efectos secundarios en cada grupo de tratamiento. Se evaluará la tolerabilidad que presentan los pacientes al tratamiento; para ello, se efectuará un cuestionario en el que se recogerá el bienestar general del paciente así como diferente sintomatología gastrointestinal La aparición de síntomas gastrointestinales como: Náuseas Vómitos Epigastralgia Cambio de coloración en las heces Estreñimiento |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Analytical parameters First Quarter Selection visit: Week 12 2nd visit: Week 16-17 3rd visit: Week 24-26 4th visit: Week 30 5th visit: Week 34-36 6th visit: Pre labour Post Labour visit: Week 2-3 puerperium
Second quarter Selection visit: Week 24 Second visit: Week 29-30 Third visit: Week 34-36 Post Labour visit: Week 2-3 puerperium
-Side effects in each treatment group First Quarter 2nd visit: Week 16-17 3rd visit: Week 24-26 4th visit: Week 30 5th visit: Week 34-36 Post Labour visit: Week 2-3 puerperium
Second quarter Second visit: Week 29-30 Third visit: Week 34-36 Post Labour visit: Week 2-3 puerperium |
- Parámetros analíticos. Primer trimestre Visita de selección: semana 12 2ª visita: semana 16-17 3ª visita: semana 24-26 4ª visita: semana 30 5ª visita: semana 34-36 6ª visita: Preparto Visita postparto: semana 2-3 puerperio
Segundo trimestre Visita de selección: semana 24 Segunda visita: semana 29-30 Tercera visita: semana 34-36 Visita postparto: semana 2-3 puerperio
-Efectos secundarios en cada grupo de tratamiento. Primer trimestre 2ª visita: semana 16-17 3ª visita: semana 24-26 4ª visita: semana 30 5ª visita: semana 34-36 Visita postparto: semana 2-3 puerperio
Segundo trimestre Segunda visita: semana 29-30 Tercera visita: semana 34-36 Visita postparto: semana 2-3 puerperio |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
12 months of enrolment period + 28 weeks of patient full participation |
12 meses de período inclusión + 28 semanas de participación del paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 15 |