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- Sperimentazione clinica NCT01600430
Vitamin D Supplementation for Extremely Preterm Infants
Early Vitamin D Supplementation for Prevention of Respiratory Morbidity in Extremely Preterm Infants: A Randomized Clinical Trial
Panoramica dello studio
Stato
Descrizione dettagliata
After informed consent obtained, infants will be randomized using computer-generated stratified randomization codes by the pharmacy. Clinicians, researcher, and primary caregivers will be masked. Subjects will be randomly assigned to one of the treatment arms or to a placebo concurrent control.
Early vitamin D supplementation/placebo will be initiated within the first 7 days after birth. Premature infants will be randomized to receive one of the 3 fixed doses of vitamin D: either placebo (zero dose), 200 IU/day, or 800 IU/day. The supplementation will be started within 72 hours of enteral feeds being initiated and will continue until postnatal day 28. After this period of supplementation, routine supplementation will be conducted in all groups.
Remnant cord blood samples will be analyzed for vitamin D levels (serum hydroxyvitamin D [25(OH)D]. Two circulating vitamin D concentrations (25(OH)D concentrations) will be measured on postnatal days 14 and 28. Urine samples will be collected weekly, to determine calcium excretion if high serum calcium concentrations are found.
Supplementation will be discontinued and infant will exit the study if surgical necrotizing enterocolitis/bowel perforation is diagnosed, if 25 (OH)D concentrations >60ng/mL (>150nmol/L; potentially toxic) are detected or, if infant NPO for greater than 24 hours. If infant made briefly NPO (<24h) for feeding intolerance, suspected sepsis, hypotension,hemodynamically significant PDA, or respiratory difficulties, enteral vitamin D will not be discontinued.
All infants will be followed to discharge for primary, secondary outcomes as well as adverse events.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
- Fase 3
Contatti e Sedi
Luoghi di studio
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Alabama
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Birmingham, Alabama, Stati Uniti, 35249
- University of Alabama at Birmingham
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Infants admitted to the Regional Newborn ICU of the University of Alabama with gestational age between 23-27 completed weeks
Exclusion Criteria:
- Major congenital/chromosomal anomalies
- Moribund infant with low likelihood of survival, in opinion of the clinical team
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: Oral Vitamin D--200 IU/day
Cholecalciferol 200 IU given orally once per day
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200 IU/day given orally once per day as one of 4 doses of 0.5ml each given every 6 hours.
Other 3 doses will be placebo (sterile water).
Duration of 28 postnatal days
Altri nomi:
800 IU/day given orally per day as 4 doses of 200 IU/0.5ml each every 6 hours.
Duration of 28 postnatal days
Altri nomi:
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Comparatore placebo: Placebo
Identical-appearing treatment that does not contain the test drug given orally four times per day.
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Sterile water 0.5ml given orally every 6 hours.
Duration of 28 postnatal days
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Comparatore attivo: Oral Vitamin D--800 IU/day
Cholecalciferol 800 IU given orally once per day
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200 IU/day given orally once per day as one of 4 doses of 0.5ml each given every 6 hours.
Other 3 doses will be placebo (sterile water).
Duration of 28 postnatal days
Altri nomi:
800 IU/day given orally per day as 4 doses of 200 IU/0.5ml each every 6 hours.
Duration of 28 postnatal days
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Total number of days alive and off respiratory support in the first 28 days
Lasso di tempo: 28 days
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The total number of days alive and off respiratory support.
Respiratory support is defined as need of supplemental oxygen and/or positive pressure ventilation to maintain normal target oxygen saturations (88-95%).
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28 days
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Serum vitamin D concentration
Lasso di tempo: Day after birth 28
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Serum vitamin D levels determined by enzyme immunoassay obtained from whole blood (remnant sample or obtained during clinical blood draw)
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Day after birth 28
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Number of sepsis episodes treated with antibiotics for at least 5 days
Lasso di tempo: Participants will be followed for the duration of hospital stay, an expected average of 4 months
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Number of episodes of culture proven or clinically suspected sepsis episodes treated with antibiotics for at least 5 days
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Participants will be followed for the duration of hospital stay, an expected average of 4 months
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Sepsis
Lasso di tempo: Participants will be followed for the duration of hospital stay, an expected average of 4 months
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Culture proven or culture negative clinically treated course consistent with sepsis
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Participants will be followed for the duration of hospital stay, an expected average of 4 months
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Need for supplemental oxygen at 36 weeks of corrected age (Physiologic definition)
Lasso di tempo: 36 weeks gestational age corrected
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A physiologic oxygen challenge test will be administered to infants from 36.0 weeks gestation to 37.0 weeks gestation to determine a need for supplemental oxygen to keep saturation levels between 88-95%.
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36 weeks gestational age corrected
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Duration of mechanical ventilation after randomization
Lasso di tempo: Participants will be followed for the duration of hospital stay, an expected average of 4 months
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Counted as number of days on which an infant is on mechanical ventilation for any part of a calendar day
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Participants will be followed for the duration of hospital stay, an expected average of 4 months
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Days alive and off mechanical ventilation in the first 28 days after birth
Lasso di tempo: 28 days
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Counted as days alive without mechanical ventilation for any part of a day
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28 days
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Number of re-intubation events
Lasso di tempo: Participants will be followed for the duration of hospital stay, an expected average of 4 months
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Counted as number of reintubations for purposes of respiratory support
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Participants will be followed for the duration of hospital stay, an expected average of 4 months
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Death
Lasso di tempo: Participants will be followed for the duration of hospital stay, an expected average of 4 months
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Cardiorespiratory failure
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Participants will be followed for the duration of hospital stay, an expected average of 4 months
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Surgical necrotizing enterocolitis or intestinal perforation
Lasso di tempo: Participants will be followed for the duration of hospital stay, an expected average of 4 months
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Radiographic documentation of pneumatosis or intestinal perforation or treatment course for clinical necrotizing enterocolitis per Bell's stage greater than 1.
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Participants will be followed for the duration of hospital stay, an expected average of 4 months
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25(OH)D concentrations >60ng/ml (150 nmol/L)
Lasso di tempo: 14 postnatal (+/- 2 days)
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Vitamin D measurement per blood obtained either centrally or by heel stick.
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14 postnatal (+/- 2 days)
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25(OH)D concentrations >60ng/ml (150 nmol/L)
Lasso di tempo: 28 days postnatal age (+/- 3 days)
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Vitamin D measurement per blood obtained either centrally or by heel stick.
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28 days postnatal age (+/- 3 days)
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Serum calcium level
Lasso di tempo: Participants will be followed for the duration of hospital stay, an expected average of 4 months
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Serum calcium measurement per blood obtained either centrally or by heel stick, performed for clinical care.
High serum calcium level is greater than 3 mmol/l of total calcium or total calcium of >12 mg/dL, or ionized calcium >2 mml/L.
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Participants will be followed for the duration of hospital stay, an expected average of 4 months
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Urine calcium level
Lasso di tempo: Participants will be followed for the duration of hospital stay, an expected average of 4 months
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Calcium measurement per urine, random sampling.
High level (>95%tile) urine calcium to creatinine ratio is >3.8 mmol/mmol.
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Participants will be followed for the duration of hospital stay, an expected average of 4 months
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Meningitis
Lasso di tempo: Participants will be followed for the duration of hospital stay, an expected average of 4 months
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Culture proven or culture negative clinically treated course consistent with meningitis
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Participants will be followed for the duration of hospital stay, an expected average of 4 months
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Altre misure di risultato
Misura del risultato |
Lasso di tempo |
---|---|
Death or Neurodevelopmental Impairment
Lasso di tempo: Birth to 22-26 months of age
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Birth to 22-26 months of age
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Collaboratori e investigatori
Collaboratori
Investigatori
- Direttore dello studio: Ariel A. Salas, MD, University of Alabama at Birmingham
Pubblicazioni e link utili
Pubblicazioni generali
- Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
- Fort P, Salas AA, Nicola T, Craig CM, Carlo WA, Ambalavanan N. A Comparison of 3 Vitamin D Dosing Regimens in Extremely Preterm Infants: A Randomized Controlled Trial. J Pediatr. 2016 Jul;174:132-138.e1. doi: 10.1016/j.jpeds.2016.03.028. Epub 2016 Apr 11.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie delle vie respiratorie
- Malattie polmonari
- Infante, neonato, malattie
- Disturbi della nutrizione
- Avitaminosi
- Malattie da carenza
- Malnutrizione
- Complicazioni della gravidanza
- Complicanze ostetriche del lavoro
- Travaglio ostetrico, prematuro
- Lesione polmonare
- Infantile, prematuro, malattie
- Lesioni polmonari indotte dal ventilatore
- Carenza di vitamina D
- Nascita prematura
- Displasia broncopolmonare
- Effetti fisiologici delle droghe
- Micronutrienti
- Agenti di conservazione della densità ossea
- Ormoni e agenti regolatori del calcio
- Vitamina D
- Colecalciferolo
- Vitamine
- Ergocalciferoli
Altri numeri di identificazione dello studio
- UAB Neo 006
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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