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

Primary Purpose

Cardiovascular Disease, Vitamin D Deficiency

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vitamin D3

Placebo

About this trial

This is an interventional treatment trial for Cardiovascular Disease focused on measuring Cardiovascular Disease, Vitamin D, Open Heart Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Inability or refusal of the patient and/or the patient's legally acceptable representative to provide written informed consent for any reason.
History of previous vitamin D supplementation > 1,000 units of vitamin D3 per day within the past three months.
Evidence of hypercalcemia on screening labs (> 10.5 milligrams per deciliter of blood).
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).
Known allergic reaction or other intolerance to oral vitamin D3.
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.
Subject participation in previous investigational interventional studies within 30 days of the current study.
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.

Sites / Locations

Intermountain Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment

Placebo/Control Arm

Arm Description

Those randomized to the treatment arm will receive three 50,000 unit oral doses of vitamin D3 supplementation.

Those randomized to the control arm will receive three oral placebo doses.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Comparison of 25(OH) vitamin D levels (ng/ml) between baseline and other time points.

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.

Percent differences in adverse clinical outcomes between the vitamin D3 supplementation treatment and placebo arms.

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.

Time to adverse clinical events stratified by vitamin D3 supplementation and placebo arms.

Full Information

NCT ID

NCT02460211

First Posted

April 8, 2015

Last Updated

April 1, 2021

Sponsor

Intermountain Health Care, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02460211

Brief Title

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

Acronym

ASSESS-D

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

July 2015 (Actual)

Primary Completion Date

October 1, 2018 (Actual)

Study Completion Date

October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Intermountain Health Care, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiovascular Disease, Vitamin D Deficiency

Keywords

Cardiovascular Disease, Vitamin D, Open Heart Surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Active Comparator

Arm Description

Those randomized to the treatment arm will receive three 50,000 unit oral doses of vitamin D3 supplementation.

Arm Title

Placebo/Control Arm

Arm Type

Placebo Comparator

Arm Description

Those randomized to the control arm will receive three oral placebo doses.

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D3

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

72 hours

Secondary Outcome Measure Information:

Title

Comparison of 25(OH) vitamin D levels (ng/ml) between baseline and other time points.

Description

Time Frame

12-24 hrs, 48 hrs, discharge (approximately 5-8 days post-surgery), 6 months

Title

Percent differences in adverse clinical outcomes between the vitamin D3 supplementation treatment and placebo arms.

Description

Time Frame

6 months

Title

Time to adverse clinical events stratified by vitamin D3 supplementation and placebo arms.

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female >= 18 years of age Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures Subject is scheduled for elective open heart surgery at Intermountain Medical Center Subject is relatively stable as assessed by the Principal Investigator Exclusion Criteria: Inability or refusal of the patient and/or the patient's legally acceptable representative to provide written informed consent for any reason. History of previous vitamin D supplementation > 1,000 units of vitamin D3 per day within the past three months. Evidence of hypercalcemia on screening labs (> 10.5 milligrams per deciliter of blood). 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). Known allergic reaction or other intolerance to oral vitamin D3. 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. Subject participation in previous investigational interventional studies within 30 days of the current study. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph B Muhlestein, MD

Organizational Affiliation

Intermountain Health Care, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Intermountain Heart Institute

City

Murray

State/Province

Utah

ZIP/Postal Code

84143

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33580636

Citation

Barker T, May HT, Doty JR, Lappe DL, Knowlton KU, Carlquist J, Konery K, Inglet S, Chisum B, Galenko O, Anderson JL, Muhlestein JB. Vitamin D supplementation protects against reductions in plasma 25-hydroxyvitamin D induced by open-heart surgery: Assess-d trial. Physiol Rep. 2021 Feb;9(3):e14747. doi: 10.14814/phy2.14747.

Results Reference

derived

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

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