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Acute Effect of Systemic Stress on Measured Blood Concentrations of 25 (OH) Vitamin D (ASSESS-D)

1 avril 2021 mis à jour par: Intermountain Health Care, Inc.
Each patient who is admitted for preoperative preparation for elective open heart surgery at Intermountain Medical Center will be invited to participate in this study. After a written informed consent is obtained, patients meeting inclusion/exclusion criteria will be randomized 1:1 to the treatment arm or placebo/control arm. Those randomized to the treatment arm will receive three 50,000 unit oral doses of vitamin D3 supplementation. The first dose will be given the evening before surgery. The second and third doses will be given either orally or per NG tube on the mornings of post-op days 1 and 2. Blood will be obtained at the following time periods: 1) At baseline pre-procedure 12 to 18 hours before planned surgery; 2) Post-operative day 1, 12 to 24 hours after surgery; 3) 48 hours after surgery; 4) 72 hours after surgery; 5) At discharge (estimated to be between 5-8 days after surgery); and 6) At the 6-month follow-up visit (post-surgery). Plasma levels of 25(OH) vitamin D will be measured on each sample.

Aperçu de l'étude

Description détaillée

Each patient who is admitted for preoperative preparation for elective open heart surgery at Intermountain Medical Center will be invited to participate in this study. The patient's history and medical records will be reviewed and data gathered will be used to evaluate the patient's relationship to inclusion and exclusion criteria. After a written informed consent is obtained, subjects will be randomized 1:1 to the treatment arm or placebo/control arm. Those randomized to the treatment arm will receive three 50,000 unit oral doses of vitamin D3 supplementation. The first dose will be given the evening before surgery. The second and third doses will be given either orally or per NG tube on the mornings of post-op days 1 and 2. Approximately 15-20 ml (about one tablespoon) of blood will be obtained at the following time periods (+/- 4 hours): 1) At baseline pre-procedure 12 to 18 hours before planned surgery; 2) Post-operative day 1, 12 to 24 hours after surgery; 3) 48 hours after surgery; 4) 72 hours after surgery; 5) At discharge (estimated to be between 5-8 days after surgery); and 6) At the 6-month follow-up visit (post-surgery). Each blood sample will be transported to The Center for Molecular and Genetic Research at LDS Hospital Cardiovascular Genetics Laboratory for preparation and storage. Plasma levels of 25(OH) vitamin D will be measured on each sample.

Type d'étude

Interventionnel

Inscription (Réel)

150

Phase

  • N'est pas applicable

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

    • Utah
      • Murray, Utah, États-Unis, 84143
        • Intermountain Heart Institute

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:

  1. Male or female >= 18 years of age
  2. Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures
  3. Subject is scheduled for elective open heart surgery at Intermountain Medical Center
  4. Subject is relatively stable as assessed by the Principal Investigator

Exclusion Criteria:

  1. Inability or refusal of the patient and/or the patient's legally acceptable representative to provide written informed consent for any reason.
  2. History of previous vitamin D supplementation > 1,000 units of vitamin D3 per day within the past three months.
  3. Evidence of hypercalcemia on screening labs (> 10.5 milligrams per deciliter of blood).
  4. Any scheduled cardiac surgical procedure that does not require open thoracotomy (the reason for this exclusion is that the study design requires that the patients will undergo a significantly stressful procedure, which can be generally guaranteed if the patient undergoes open thoracotomy).
  5. Known allergic reaction or other intolerance to oral vitamin D3.
  6. Pregnant and/or lactating women and women of child bearing potential who are not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the Principal Investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen.
  7. Subject participation in previous investigational interventional studies within 30 days of the current study.
  8. Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.

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: Treatment
Those randomized to the treatment arm will receive three 50,000 unit oral doses of vitamin D3 supplementation.
Those randomized to the treatment arm will receive three 50,000 unit oral doses of vitamin D3 supplementation. The first dose will be given the evening before surgery. The second and third doses will be given either orally or per NG tube on days 1 and 2 after surgery.
Comparateur placebo: Placebo/Control Arm
Those randomized to the control arm will receive three oral placebo doses.
Those randomized to the control arm will receive three placebo doses. The first dose will be given the evening before surgery. The second and third doses will be given either orally or per NG tube on days 1 and 2 after surgery.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Changes in 25(OH) vitamin D levels (ng/ml) between baseline (pre-surgery) and 72 hours post-surgery.
Délai: 72 hours
72 hours

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Comparison of 25(OH) vitamin D levels (ng/ml) between baseline and other time points.
Délai: 12-24 hrs, 48 hrs, discharge (approximately 5-8 days post-surgery), 6 months
Subjects will be re-assessed on post-operative day 1 (12-24 hours after surgery), then at 48 and 72 hours post-surgery, at discharge (approximately 5-8 days post-surgery), and at a 6 month post-surgery follow-up visit.
12-24 hrs, 48 hrs, discharge (approximately 5-8 days post-surgery), 6 months
Percent differences in adverse clinical outcomes between the vitamin D3 supplementation treatment and placebo arms.
Délai: 6 months
Clinical outcomes that will be monitored include: death, myocardial infarction, stroke, repeat coronary revascularization or hospitalization for heart failure, worsening of renal function, hospitalization for pneumonia or other acute systemic infection or any other serious adverse clinical event.
6 months
Time to adverse clinical events stratified by vitamin D3 supplementation and placebo arms.
Délai: 6 months
Clinical outcomes that will be monitored include: death, myocardial infarction, stroke, repeat coronary revascularization or hospitalization for heart failure, worsening of renal function, hospitalization for pneumonia or other acute systemic infection or any other serious adverse clinical event.
6 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Joseph B Muhlestein, MD, Intermountain Health Care, Inc.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

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 (Réel)

1 juillet 2015

Achèvement primaire (Réel)

1 octobre 2018

Achèvement de l'étude (Réel)

1 octobre 2020

Dates d'inscription aux études

Première soumission

8 avril 2015

Première soumission répondant aux critères de contrôle qualité

29 mai 2015

Première publication (Estimation)

2 juin 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 avril 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 avril 2021

Dernière vérification

1 avril 2021

Plus d'information

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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