E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute bronchitis Upper airway infection |
Bronquitis aguda Infección de vía aérea superior |
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E.1.1.1 | Medical condition in easily understood language |
Acute bronchitis Upper airway infection |
Bronquitis aguda Infección de vía aérea superior |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000687 |
E.1.2 | Term | Acute bronchitis |
E.1.2 | System Organ Class | 100000004862 |
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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 |
Check that the administration of a vitamin D dose of 1,000 U / day decreases the percentage of children with acute bronchitis during the first year of life. |
Comprobar que la administración de una dosis de vitamina D de 1.000 U/día disminuye el porcentaje de niños que presentan bronquitis agudas durante el primer año de vida. |
|
E.2.2 | Secondary objectives of the trial |
Check that the supplementation of vitamin D of 1,000 units / day decreases the number of upper respiratory infections and recurrent bronchitis.
Check that the administration of 1,000 U / day of vitamin D decreases the percentage of children under one year of age hospitalized for acute bronchiolitis.
Check that the supplementation of vitamin D 1,000 units / day manages to get a higher percentage of children with proper blood levels of 25 OH vitamin D3.
Check that the administration of 1,000 U / day of vitamin D reduces the use of health care and absence from work of parents due to respiratory infections |
Comprobar que la administración de una dosis de vitamina D de 1.000 U/día disminuye el porcentaje de niños que presentan bronquitis recurrentes durante el primer año de vida. Comprobar que la administración de 1.000 U/día de vitamina D disminuye el porcentaje de niños menores de un año de edad que ingresan por bronquiolitis aguda. Comprobar que la administración de un suplemento de vitamina D de 1.000 unidades/día disminuye el número de infecciones respiratorias de vías altas. Comprobar que la administración de un suplemento de vitamina D de 1.000 unidades/día logra obtener un mayor porcentaje de niños con niveles sanguíneos correctos de 25-OH vitamina D3. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy on-term newborns of appropriate size for gestational age during the first 2 weeks of age (range 5 days), on exclusive breastfeeding or exclusive formula feeding. Newborns whose parents authorize the inclusion in the study |
Recién nacidos a término sanos de tamaño adecuado para la edad gestacional durante las 2 primeras semanas de vida (margen 5 días) Estar recibiendo lactancia materna exclusiva o lactancia artificial exclusiva Recién nacidos cuyos padres autoricen la inclusión en el estudio |
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E.4 | Principal exclusion criteria |
Infants with gestational age <37 weeks Low birth weight for gestational age (birth weight <2,500 g) Mixed feeding at baseline Newborns with major congenital anomalies Infants with chronic gastrointestinal, hepatic, renal, respiratory, cardiac, neurological, or metabolic disorders Any disease that is accompanied by hypercalcemia and hypercalciuria, calcium lithiasis, hypersensitivity to vitamin D, hypervitaminosis D, renal osteodystrophy with hyperphosphatemia |
Recién nacidos con edad gestacional < 37 semanas Recién nacidos de bajo peso para la edad gestacional (peso al nacer < 2.500 g) Estar recibiendo lactancia mixta en la visita basal Recién nacidos con anomalías congénitas mayores Recién nacidos con enfermedades crónicas gastrointestinales, hepáticas, renales, respiratorias, cardiacas, neurológicas, o trastornos del metabolismo Cualquier patología que se acompañe de hipercalcemia e hipercalciuria, litiasis cálcica, hipersensibilidad a la vitamina D, hipervitaminosis D y osteodistrofia renal con hiperfosfatemia |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of children with acute bronchitis . |
Porcentaje de niños que presentan bronquitis agudas |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Percentage of children with recurrent bronchitis.
Number of episodes of upper respiratory infections reported by parents in the first year of life
Number of infants hospitalized for acute bronchiolitis
Levels of 25-OH vitamin D3 (parameter of efficacy and safety)
Blood calcium levels and calcium / creatinine ratio in a single urination (security settings).
Growth: weight, length and head circumference (security settings). |
Porcentaje de niños que presentan bronquitis recurrentes
Número de episodios de infecciones respiratorias de vías altas comunicados por los padres en el primer año de vida
Número de lactantes hospitalizados por bronquiolitis aguda
Niveles de 25-OH vitamina D3 (parámetro de eficacia y seguridad)
Niveles de calcio en sangre, y calcio/creatinina en orina en una micción única (parámetros de seguridad).
Crecimiento: peso, talla y perímetro cefálico (parámetros de seguridad). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2, 6, 12 months |
2, 6, 12 meses |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Dosis más baja del IMP |
Lower dose of IMP |
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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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
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
|
Last visit of the last subject undergoing the trial. |
Última visita del último sujeto del ensayo. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |