- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01689779
High Dose Preoperative Cholecalciferol Supplementation and Perioperative Vitamin D Status
29 août 2017 mis à jour par: Sadeq A. Quraishi, Massachusetts General Hospital
Effect of High-dose Cholecalciferol Supplementation on Perioperative Vitamin D Status in Colorectal Surgery Patients
A growing body of evidence suggests that robust postoperative immune function is associated with a lower risk of surgical site infections (SSIs).
At the same time, vitamin D is increasingly recognized as a key regulator of the innate and adaptive immune systems.
The investigators elected to conduct the current study in patients who will undergo colorectal surgery since these patients are historically at higher risk of developing SSIs and therefore would be ideal for future investigations.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
While vitamin D insufficiency [25(OH)D <30 ng/mL] is common in the general population, hypovitaminosis D may affect 40-80% of patients in the perioperative setting.
Recent evidence also suggests that surgical stress may be associated with a 40% reduction in circulating 25(OH)D levels when compared to preoperative values.
Moreover, the derangement in perioperative 25(OH)D levels may be sustained for up to 3 months after surgery.
This finding has potential implications regarding modifiable risk factors for surgical site infections (SSIs), which account for nearly 40% of all nosocomial infections.
On aggregate, SSIs result in 3.7 million extra hospital days per annum and an added burden of $1.6 billion in annual healthcare costs.
A growing body of evidence suggests that robust postoperative immune function is associated with a lower risk of SSIs.
At the same time, vitamin D is increasingly recognized as a key regulator of the innate and adaptive immune systems.
Yet, optimization of perioperative vitamin D status remains grossly understudied.
Although our overarching aim is to study the impact of vitamin D status on SSIs, the focus of the current investigation is to determine whether the administration of a "bolus" oral dose of cholecalciferol (vitamin D3) in the preoperative setting alters vitamin D status in the perioperative setting (compared to a placebo).
The investigators elected to conduct the current study in patients who will undergo colorectal surgery since these patients are historically at higher risk of developing SSIs and therefore would be ideal for future investigations.
Type d'étude
Interventionnel
Inscription (Réel)
60
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Men and women;
- 18 years or older;
- Scheduled for elective (non-emergent) colorectal surgery;
- Cleared for anesthesia; and
- Expected to stay overnight following surgery
Exclusion Criteria:
- Scheduled for a purely laparoscopic procedure;
- Diagnosis of a terminal illness and/or in hospice care;
- Inability to sign informed consent;
- Inability to comply with study protocol;
- Intending to start vitamin D supplementation within 30 days of surgery;
- Intending to leave the Boston area during the follow-up period;
- History of renal stones or hypercalcemia;
- Medical conditions that can cause hypercalcemia (e.g. metastatic cancer, sarcoidosis, myeloma primary hyperparathyroidism)
- History of hypercalcemia
- History of severe anemia (Hematocrit <25%)
- Medications that affect vitamin D metabolism (e.g. anti-epileptics, tuberculosis medication); and
- Already enrolled or planning to enroll in a research study that would conflict with full participation in the current study or confound the observation or interpretation of the study findings
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Cholecalciferol
A maximum of 40 patients will receive a one-time oral dose of 100,000 IU cholecalciferol 3-7 days before their scheduled elective surgery.
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active drug
Autres noms:
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Comparateur placebo: Placebo
A maximum of 40 patients will receive a one-time oral sugar pill 3-7 days before their scheduled elective surgery.
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comparator drug
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Percent (%) Change in 25(OH)D 5 Days Following Supplementation With 100,000 IU Cholecalciferol
Délai: Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days
|
3-7 days before surgery, patients will receive 100,000 IU of cholecalciferol (vs.
placebo) during their pre-op assessment.
They will also have their baseline vitamin D status measured during this initial visit.
The main study outcome is to determine if 100,000 IU cholecalciferol can be given preoperatively to safely boost vitamin D status.
To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37
|
Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days
|
Percent (%) Change in LL-37 5 Days Following Supplementation With 100,000 IU Cholecalciferol
Délai: Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days
|
3-7 days before surgery, patients will receive 100,000 IU of cholecalciferol (vs.
placebo) during their pre-op assessment.
They will also have their baseline vitamin D status measured during this initial visit.
The main study outcome is to determine if 100,000 IU cholecalciferol can be given preoperatively to safely boost vitamin D status.
To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37
|
Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Percent (%) Change in Pre-surgical 25(OH)D Within 24 Hours of Surgery
Délai: Patients will be followed between the day of surgery and 1 day after surgery
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The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs.
placebo) alters the natural course of short-term changes in vitamin D status following surgery.
To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37.
|
Patients will be followed between the day of surgery and 1 day after surgery
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Percent (%) Change in Pre-surgical LL-37 Within 24 Hours of Surgery
Délai: Patients will be followed between the day of surgery and 1 day after surgery
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The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs.
placebo) alters the natural course of short-term changes in vitamin D status following surgery.
To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37.
|
Patients will be followed between the day of surgery and 1 day after surgery
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Percent (%) Change in Pre-surgical 25(OH)D 2 Weeks After Surgery
Délai: Patients will be followed between the day of surgery and an average duration of 14 days after surgery
|
The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs.
placebo) alters the natural course of changes in vitamin D status within 10-18 days after surgery.
To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL-37.
|
Patients will be followed between the day of surgery and an average duration of 14 days after surgery
|
Percent (%) Change in Pre-surgical LL-37 2 Weeks After Surgery
Délai: Patients will be followed between the day of surgery and an average duration of 14 days after surgery
|
The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs.
placebo) alters the natural course of changes in vitamin D status within 10-18 days after surgery.
To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL-37.
|
Patients will be followed between the day of surgery and an average duration of 14 days after surgery
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Sadeq A Quraishi, MD, MHA, Massachusetts General Hospital
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 janvier 2013
Achèvement primaire (Réel)
1 mai 2015
Achèvement de l'étude (Réel)
1 mai 2015
Dates d'inscription aux études
Première soumission
4 septembre 2012
Première soumission répondant aux critères de contrôle qualité
17 septembre 2012
Première publication (Estimation)
21 septembre 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 septembre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 août 2017
Dernière vérification
1 août 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies métaboliques
- Troubles nutritionnels
- Maladies musculo-squelettiques
- Maladies de carence
- Malnutrition
- Maladies osseuses
- Maladies osseuses métaboliques
- Troubles du métabolisme calcique
- Carence en vitamine D
- Rachitisme
- Avitaminose
- Effets physiologiques des médicaments
- Micronutriments
- Vitamines
- Agents de conservation de la densité osseuse
- Hormones et agents régulateurs du calcium
- Vitamine D
- Cholécalciférol
Autres numéros d'identification d'étude
- 2012P001852
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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