High Dose Preoperative Cholecalciferol Supplementation and Perioperative Vitamin D Status
2017年8月29日 更新者: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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
60
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ: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
他の名前:
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プラセボコンパレーター: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
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percent (%) Change in 25(OH)D 5 Days Following Supplementation With 100,000 IU Cholecalciferol
時間枠:Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days
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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
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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
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percent (%) Change in Pre-surgical 25(OH)D Within 24 Hours of Surgery
時間枠: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
時間枠: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
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percent (%) Change in Pre-surgical 25(OH)D 2 Weeks After Surgery
時間枠: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
時間枠: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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者:Sadeq A Quraishi, MD, MHA、Massachusetts General Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2013年1月1日
一次修了 (実際)
2015年5月1日
研究の完了 (実際)
2015年5月1日
試験登録日
最初に提出
2012年9月4日
QC基準を満たした最初の提出物
2012年9月17日
最初の投稿 (見積もり)
2012年9月21日
学習記録の更新
投稿された最後の更新 (実際)
2017年9月28日
QC基準を満たした最後の更新が送信されました
2017年8月29日
最終確認日
2017年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2012P001852
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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