- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01689779
High Dose Preoperative Cholecalciferol Supplementation and Perioperative Vitamin D Status
29 augusti 2017 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
60
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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.
|
active drug
Andra namn:
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Placebo-jämförare: Placebo
A maximum of 40 patients will receive a one-time oral sugar pill 3-7 days before their scheduled elective surgery.
|
comparator drug
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percent (%) Change in 25(OH)D 5 Days Following Supplementation With 100,000 IU Cholecalciferol
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percent (%) Change in Pre-surgical 25(OH)D Within 24 Hours of Surgery
Tidsram: Patients will be followed between the day of surgery and 1 day after surgery
|
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
|
|
Percent (%) Change in Pre-surgical LL-37 Within 24 Hours of Surgery
Tidsram: Patients will be followed between the day of surgery and 1 day after surgery
|
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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percent (%) Change in Pre-surgical 25(OH)D 2 Weeks After Surgery
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Sadeq A Quraishi, MD, MHA, Massachusetts General Hospital
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2013
Primärt slutförande (Faktisk)
1 maj 2015
Avslutad studie (Faktisk)
1 maj 2015
Studieregistreringsdatum
Först inskickad
4 september 2012
Först inskickad som uppfyllde QC-kriterierna
17 september 2012
Första postat (Uppskatta)
21 september 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 september 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 augusti 2017
Senast verifierad
1 augusti 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Metaboliska sjukdomar
- Näringsstörningar
- Muskuloskeletala sjukdomar
- Bristsjukdomar
- Undernäring
- Skelettsjukdomar
- Skelettsjukdomar, metaboliska
- Kalciummetabolismstörningar
- D-vitaminbrist
- Engelska sjukan
- Avitaminos
- Läkemedels fysiologiska effekter
- Mikronäringsämnen
- Vitaminer
- Bendensitetsbevarande medel
- Kalciumreglerande hormoner och medel
- Vitamin D
- Kolekalciferol
Andra studie-ID-nummer
- 2012P001852
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
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