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Therapeutic Benefit of Preoperative Supplemental Vitamin D in Patients Undergoing Major Surgical Procedures.

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ClinicalTrials.gov Identifier: NCT02138591
Recruitment Status : Withdrawn
First Posted : May 14, 2014
Last Update Posted : June 16, 2017
Sponsor:
Collaborator:
Truman Medical Center
Information provided by (Responsible Party):
Dustin Neel, University of Missouri, Kansas City

Brief Summary:
Vitamin D (Vitamin D) deficiency is very common. We recently showed that 97% of 204 patients admitted to Truman Medical Center were Vitamin D deficient (<30 ng/ml). However, the consequences of Vitamin D deficiency, particularly with respect to infection, are not well understood. It is known that production of cathelicidin, an important antimicrobial peptide, is critically dependent upon Vitamin D. It is also established that levels of cathelicidin correlate inversely with urinary tract infection risk. We hypothesize that restoration of Vitamin D levels to normal in patients undergoing major surgery will result in significant decreases in levels of perioperative infections due to restoration of normal levels of circulating Vitamin D, which in turn will elevate cathelicidin levels. As an initial test of this hypothesis, we propose a double-blind, prospective, randomized study of pre-operative Vitamin D supplementation. Fifty subjects undergoing surgery will receive daily Vitamin D3 (50,000 IU) for five days pre-operatively, with controls receiving placebo. Levels of Vitamin D, calcium, cathelicidin, and the pro-inflammatory protein resistin, will be monitored before Vitamin D supplementation (pre-operatively) and after Vitamin D supplementation (post-operative days 1 and 2). The effect of these changes should be to decrease the incidence of infectious complications. We expect to observe Vitamin D levels increase to normal, and cathelicidin levels become elevated. We expect to see increased levels of resistin in patients developing infections. This study will provide strong pilot evidence for future NIH funding.

Condition or disease Intervention/treatment Phase
Vitamin d Deficiency Procedure: Blood draw pre-operatively Procedure: Blood draw post-operative Day 1 Procedure: Blood draw post-operative Day 2 Phase 3

Detailed Description:

The long term goal in our research is to develop and implement effective, evidence-and mechanism-based interventions to improve outcomes for surgical and trauma patients. Of potential importance, findings from our own recent pilot studies have established that > 95% of patients seen at Truman Medical Center (TMC) are seriously Vitamin D deficient with plasma levels significantly lower than normal. Our objective in this application, therefore, is to assess the short term therapeutic benefit of high dose Vitamin D in patients admitted to TMC for elective major abdominal surgery. We propose to measure plasma Vitamin D and Calcium levels before supplementation (pre-operatively), and after supplementation (post-operatively), and monitor the biomarker proteins cathelicidin and resistin at the same times. Data on Vitamin D levels will be used to assess direct biochemical effects. Measurement of cathelicidin levels will provide additional information. Since Vitamin D has been shown to induce increased expression of this antimicrobial protein. Monitoring of circulating levels of resistin provides a highly sensitive early measure of infection (unpublished observations). Calcium levels will also be monitored since there is a significant chance that pre-operative calcium levels will be low in some patients, and that supplementation with vitamin D may increase the calcium level.

Measures of secondary clinical outcomes will include length of hospital stay and incidence of post-operation infection. Our central hypothesis is that, relative to patients receiving peri-operative standard of care, patients receiving 250,000 units of Vitamin D pre-operatively will manifest levels of Vitamin D to within the normal range and will have elevated levels of cathelicidin. We further hypothesize that patients receiving Vitamin D will have reduced incidence of infection, which will correlate with lower levels of resistin, and will exhibit trends toward shorter hospital stay. Our proposed specific aims are:

Specific Aim #1: Determine biochemical consequences of Vitamin D supplementation in elective surgery patients We hypothesize that preoperative supplementation with high dose Vitamin D will result in levels of Vitamin D in treated patients within the normal range, corresponding with significant increases in plasma levels of cathelicidin, relative to control patients receiving standard of care.

Specific Aim # 2: Evaluate clinical benefits of Vitamin D supplementation in post-elective surgery patients We postulate that patients given Vitamin D will trend toward lower rates of post-surgery infection, as evidenced by the absence of circulating resistin and decreased detection of pulmonary or wound-site infection, and will have shorter hospital stays relative to patients receiving standard of care.

It is our expectation that, at the completion of this pilot study, we will have provided strong evidence that plasma levels of Vitamin D, as measured by 25-OHD, can be reproducibly raised to normal levels as measured in post-surgery patients and that the administered Vitamin D will have detectable biochemical benefits. We further expect that, while the power of the proposed study will not be sufficient for statistically valid results, there will be trends toward clinical benefits in Vitamin D treated patients. Collectively, these findings would provide strong evidence to support feasibility of an NIH-supported Phase I trial to assess Vitamin D benefits in surgery and/or trauma.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Therapeutic Benefit of Preoperative Supplemental Vitamin D in Patients Undergoing Major Surgical Procedures.
Study Start Date : February 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Vitamin D3

Vitamin D3 (cholecalciferol) 50,000 IU by mouth daily for each of the five days prior to surgery.

Blood draw pre-operatively Blood draw post-operative Day 1 Blood draw post-operative Day 2

Procedure: Blood draw pre-operatively
Pre-Operative blood draw of approximately 32ml will check the following: Vitamin D (25-OHD), Calcium, Cathelicidin and Resistin levels in the blood.
Other Name: Venipuncture

Procedure: Blood draw post-operative Day 1
Blood draw of approximately 32ml to check the following: Vitamin D (25-OHD), Calcium, Cathelicidin and Resistin levels in the blood.
Other Name: Venipuncture

Procedure: Blood draw post-operative Day 2
Blood draw of approximately 32ml to check the following: Vitamin D (25-OHD), Calcium, Cathelicidin and Resistin levels in the blood.
Other Name: Venipuncture

Placebo Comparator: Placebo pill
Placebo pill by mouth daily for each of the five days prior to surgery. Blood draw pre-operatively Blood draw post-operative Day 1 Blood draw post-operative Day 2
Procedure: Blood draw pre-operatively
Pre-Operative blood draw of approximately 32ml will check the following: Vitamin D (25-OHD), Calcium, Cathelicidin and Resistin levels in the blood.
Other Name: Venipuncture

Procedure: Blood draw post-operative Day 1
Blood draw of approximately 32ml to check the following: Vitamin D (25-OHD), Calcium, Cathelicidin and Resistin levels in the blood.
Other Name: Venipuncture

Procedure: Blood draw post-operative Day 2
Blood draw of approximately 32ml to check the following: Vitamin D (25-OHD), Calcium, Cathelicidin and Resistin levels in the blood.
Other Name: Venipuncture




Primary Outcome Measures :
  1. Change in Vitamin D level as measured as 25-OHD level [ Time Frame: Pre-operatively, Post-operative Day 1 and Postoperative Day 2 ]
    Change in Vitamin D level from Pre-Operatively to Post-Operative Day 1 and Post-Operative Day 2


Secondary Outcome Measures :
  1. Change in Resistin level in the blood [ Time Frame: Pre-operatively, Post-operative Day 1, Post-operative Day 2 ]
    Change in Resistin level from Pre-Operatively to Post-Operative Day 1 and Post-Operative Day 2

  2. Change in Cathelicidin level in the blood [ Time Frame: Pre-operatively, Post-operative Day 1, Post-operative Day 2 ]
    Change in Cathelicidin level from Pre-Operatively to Post-Operative Day 1 and Post-Operative Day 2

  3. Change in Calcium Level in the blood [ Time Frame: Pre-operatively, Post-operative Day 1, Post-operative Day 2 ]
    Change in Calcium level from Pre-Operatively to Post-Operative Day 1 and Post-Operative Day 2



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English Speaking
  • Age 18 years or older
  • Patient undergoing major elective surgery with planned open abdominal incisions, and planned hospitalization of two days or longer.

Exclusion Criteria:

  • Pregnant
  • Non-English Speaking
  • Chronic severe kidney disease (Stage III, IV, V)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138591


Locations
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United States, Missouri
Truman Medical Center Hospital Hill
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
University of Missouri, Kansas City
Truman Medical Center
Investigators
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Study Director: Charles Van Way III, M.D. Truman Medical Center and University of Missouri Kansas City
Principal Investigator: Dustin Neel, MD Truman Medical Center and University of Missouri Kansas City
Publications:
Serrone R, Loveless B, Frankel E, Ross V, Geehan D, Van Way, CW III. vitamin D Deficiency in Patients Admitted to a Midwestern Urban Hospital. Poster presentation at Clinical Nutrition Week, American Society of Parenteral and Enteral Nutrition, Phoenix, AZ, 2013

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Responsible Party: Dustin Neel, Co-Principal Investigator, University of Missouri, Kansas City
ClinicalTrials.gov Identifier: NCT02138591    
Other Study ID Numbers: 14-149
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Keywords provided by Dustin Neel, University of Missouri, Kansas City:
vitamin d deficiency
cathelicidin antimicrobial peptide
resistin, human
protein, human
1,25-dihydroxy-16,23-diene vitamin D3
Cholecalciferol
Nutritional Status
length of stay
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders