Clinical trial: NCT02881957
Section: Alternatives
Subsections: Alternative Procedures

You may choose not to participate in this study. If you do not want to take part in the study you will continue to be monitored for the effects of low vitamin D. Patients with very low vitamin D levels (<10 ng/mL) will received vitamin D supplementation based on the standard practice in the neurocritical care unit. You will not be contacted by the research team any further.
Clinical trial: NCT02881957
Section: Confidentiality
Subsections: Authorization For Use Of Your Protected Health Information|How We Will Protect And Share Your Information:

Signing this document means you allow us, the researchers in this study, and others working with us to use some information about your health for this research study.  
This is the information we will use and include in our research records:
-Demographic and identifying information like name, medical record number, date of birth, gender, diagnosis, ethnicity/race, dates of admission and discharge
-Related medical information about you like past medical history, past surgical history, current and past medications or therapies, information from physical examinations, vital signs, and lab results.  
-All tests and procedures that will be done in the study.  
| University of Utah                                                                    |
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| Institutional Review Board Approved 9/13/2017 Expires 9/12/2018 11:59 PM IRB_00091541 |

We will do everything we can to keep your information private but we cannot guarantee this.  
Study information will be kept in a secured manner and electronic records will be password protected. Study information may be stored with other information in your medical record. Other doctors, nurses, and third parties (like insurance companies) may be able to see this information as part of the regular treatment, payment, and health care operations of the hospital. We may also need to disclose information if required by law.  
All investigators on this trial have signed conflicts-of-interest disclosures and confidentiality agreements that are available on file with the IRB and FDA.  
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.  
In order to conduct this study and make sure it is conducted as described in this form, the research records may be used and reviewed by others who are working with us on this research:
o Members of the research team and the University of Utah Health Sciences Center; o The University of Utah Institutional Review Board (IRB), which reviews research involving people to make sure the study protects your rights; o The Food and Drug Administration reviews data from all clinical trials in the U.S. to ensure data quality and patient safety.  
If you do not want us to use information about your health, you should not be part of this research. If you choose not to participate, you can still receive health care services at University of Utah Health Sciences Center.  
If we share your identifying information with groups outside of the University of Utah Health Sciences Center, they may not be required to follow the same federal privacy laws that we follow. They may also share your information again with others not described in this form.
Clinical trial: NCT02881957
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks|Reproductive Risks|Research-Related Injury

Rare adverse risks of vitamin D include hypercalcemia, or high calcium in the blood stream, impairment of kidney function, calcification of the soft tissues, osteoporosis, nausea, constipation, and anemia. Vitamin D is an over-the-counter medication and we prescribe it as a standard-of-care for patients in the Neurocritical care unit. Our observational study of 823 patients did not show any adverse effect for vitamin D supplementation. Nor has any record of adverse effect at the dosages used in this study been reported. Nevertheless, patients in this study will be closely monitored by the ICU and neurosurgery/neurology teams, and, in the event that an adverse effect associated with the study medication is seen, the patient will be promptly discontinued from the trial.

There are no known risks of vitamin D supplementation in pregnant women and daily supplementation is recommended. However, patients that are pregnant will not be eligible for this trial because the doses used are higher than the recommended daily supplementation rate and the risks to the baby are unknown at this dose. Women who are at risk of pregnancy will be asked to have a pregnancy test before taking part to exclude the possibility of pregnancy. There will be no need for birth control for this research project. As the treatment is a single dose, it will not affect future risks to the embryo or fetus. For studies involving possible reproductive risks, please include a section that includes the following:

If you are injured from being in this study, medical care is available to you at the University of Utah, as it is to all sick or injured people. The University of Utah has not set aside any money to pay the costs for such care. The University will work with you to address costs from injuries. Costs would be charged to you or your insurance company (if you have insurance), to the study sponsor or other third party (if applicable), to the extent those parties are responsible for paying for medical care you receive. Since this is a research study, some health insurance plans may not pay for the costs. By signing this consent form you are not giving up your right to pursue legal action against any parties involved with this research. The University of Utah is a part of the government. If you are injured in this study, and want to sue the University or the doctors, nurses, students, or other people who work for the University, special laws may apply. The Governmental Immunity Act of Utah is a law that controls when a person needs to bring a claim against the government, and limits the amount of money a person may recover. See sections 63G -7-101 to -904 of the Utah Code.
Clinical trial: NCT02881957
Section: Procedures
Subsections: Study Procedures

A research trial usually involves comparing different treatments. In a trial, one group will get one treatment and another group will get a different treatment. In a "randomized trial" people are put in one group or the other by random chance. This means that a computer will decide by chance which group a person is in, not the doctors running the trial. The trial is double blind, which means neither you  
| University of Utah                                                                    |
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| Institutional Review Board Approved 9/13/2017 Expires 9/12/2018 11:59 PM IRB_00091541 |  
  
Page 2 of 8 V5, Aug 2017 nor your doctor will know which treatment group you are in (although, if your doctor needs to find out for important medical reasons, he/she can do so).  
You have been identified as a patient with low vitamin D levels (<20ng/mL) and eligible for this study.  
You will be randomly assigned (similar to flipping a coin) to one of two groups being compared in this study. You will either cholecalciferol/vitamin D3 supplementation (540,000 IU once orally or by feeding tube) or an oral sugar pill (placebo). A placebo is a dummy treatment such as a pill which looks like the pill that contains the study drug but is not. Placebos contain no drugs or active ingredients. Study participants are given placebos so that the effects of a drug can be compared against no drug. Use of placebos also prevents the participant and the doctor from knowing whether or not the subject is getting the drug.  
Regardless of what group you are assigned to, your clinical exam, clinical course and laboratory studies will be closely monitored. This will be used for the study and to ensure patient safety. Prior to discharge you will receive a quality-of-life survey, a standardized metric for evaluating the impact of a disease on your health. This will be repeated at your followup appointment, 3 months and 6 months.
Clinical trial: NCT02881957
Section: Voluntary Participation
Subsections: Voluntary Participation

| University of Utah                                                                    |
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| Institutional Review Board Approved 9/13/2017 Expires 9/12/2018 11:59 PM IRB_00091541 |  
  
Page 4 of 8 V5, Aug 2017 It is up to you to decide whether or not to take part in this study. If you decide to take part you are still free to withdraw at any time and without giving a reason. Refusal to participate or the decision to withdraw from this study will involve no penalty or loss of benefits to which you are otherwise entitled.  
If you don't take part, you can still receive all standard care that is available to you. This will not affect the relationship you have with your doctor or other staff, nor decrease the standard of care that you receive as a patient.  
If you want to stop being in this study, please let the research doctor know. That way you can find out what should be done about your routine care outside of the study.
Clinical trial: NCT02881957
Section: Withdrawal from Study
Subsections: What If I Decide To Not Participate After I Sign The Consent And Authorization Form?

You can tell us anytime that you do not want to be in this study and do not want us to use your health information. You can also tell us in writing. If you change your mind, we will not be able to collect new information about you, and you will be withdrawn from the research study. However, we can continue to use information we have already started to use in our research, as needed to maintain the integrity of the research. This authorization does not have an expiration date.  
| University of Utah                                                                    |
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| Institutional Review Board Approved 9/13/2017 Expires 9/12/2018 11:59 PM IRB_00091541 |  
  
Page 6 of 8 V5, Aug 2017 You have a right to information used to make decisions about your health care. However, your information from this study will not be available during the study; it will be available after the study is finished.  
| University of Utah                                                                    |
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| Institutional Review Board Approved 9/13/2017 Expires 9/12/2018 11:59 PM IRB_00091541 |  
  
CONSENT I confirm that I have read this consent and authorization document and have had the opportunity to ask questions. I will be given a signed copy of the consent and authorization form to keep. I agree to take part in this research study and authorize you to use and disclose health information about me for this study, as you have explained in this document.  
________________________
Participant's Name
________________________ ____________ Participant's Signature Date ________________________ Name of Person Obtaining Authorization and Consent ________________________ ____________ Signature of Person Obtaining Authorization and Consent Date