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

NCT02460211 | Completed DMC

• 1 other identifier: 1040458
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Vitamin D Deficiency

Keywords

Cardiovascular Disease; Vitamin D; Open Heart Surgery

Outcome Measures

Primary Outcomes (1)

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

  72 hours

Secondary Outcomes (3)

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

  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.

  6 months

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

  6 months

Study Arms (2)

Treatment

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin D3

Placebo/Control Arm

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

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.

Treatment

Placebo DIETARY_SUPPLEMENT

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.

Placebo/Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Heart Institute

Murray, Utah, 84143, United States

Location

Related Publications (1)

• 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.

  PMID: 33580636 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Joseph B Muhlestein, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: June 2, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2020
• Last Updated: April 5, 2021

Record last verified: 2021-04

Locations

US (1)