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

NCT02460211 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-04-05

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Vitamin D3

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.

DIETARY_SUPPLEMENT

Placebo

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.

Sponsors & Collaborators

  • Intermountain Health Care, Inc.

    lead OTHER

Principal Investigators

  • Joseph B Muhlestein, MD · Intermountain Health Care, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2018-10-01
Completion
2020-10-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02460211 on ClinicalTrials.gov