Name _______________________________ DOB ____ / ____ / ____ Age____ yrs

Must be ≥ 30

BMI Range 25-40 kg/m², inclusive

Phone __________________________ E-mail _______________________________

Height ____ ft ____ in Weight ___ ___ ___ pounds BMI ___ ___ . ____ kg/m2

Current Medications: ________________________________________________

(Use back of page if necessary

__________________________________________________________________

Screening Eligibility Criteria

Answer based on above information (highlighted responses are exclusionary):

Yes No	Volunteer is aged < 30 years?

Yes No	BMI (above) is < 25 (23 kg/m² for Asians) or > 40 kg/m²

Yes No	Use of anticonvulsant drugs started within last 6 months

Yes No	Use of thiazide diuretics at a total dose > 37.5 mg/day

Yes No	Use of supplements containing Vitamin D at doses > 1000 IU/day within last 12 weeks

Yes No	Volunteer has taken a weight loss medication in the last 3 months?

Yes No	Volunteer has taken oral or intravenous glucocorticoids in the last 6 months?

Answer based on volunteer’s response:

Yes No	History of intolerance to Vitamin D?

Yes No	Use of oral or injectable medications for type 2 diabetes in the past year or diagnosed with type 2 diabetes?

Yes No	Do you have high blood pressure that does not go down with medication?

Yes No	Do you have a history of heart (CHF), liver or lung (COPD) disease?

Yes No	History of kidney disease/kidney stones, abnormal parathyroid or elevated calcium?

Yes No	Have you use tanning beds in the last 12 weeks?

Yes No	Any cancer in last 5 years? (basal cell is okay) Prostate cancer for men over 55 or thyroid cancer that requires treatment over the next 4 years?

Yes No	Have you had major surgery on the abdomen, pelvis, or lower extremities within the past 3 months?

Yes No	Have you had bariatric surgery or planned bariatric surgery in the next 3 years?

Yes No	Volunteer has donated blood in the last 3 months? Received blood in last 6 months?

Yes No	Have you participated in another interventional study in last 30 days?

Yes No	History, within the last year, of substance abuse or unstable psychiatric disorder?

Females:

Yes No	Have you been pregnant or nursed a child within the past 12 months or intend to become pregnant in the next 4 years?

About Participation

If any of the Screening Eligibility Criteria are answered “Yes”:

Unfortunately, based on the information you provided, you do not qualify for our current study; however, you may qualify for future studies. May we contact you for future studies?  No  Yes, best way to contact: Phone, Email, Other:_________________________________

If ALL of the Screening Eligibility Criteria are answered “No”:

Congratulations, based on the information you provided, you may qualify for our current study.

This study requires a total of 12 visits to our office over a 4 year period. The first visit is a screening visit. At this visit, you will read an Informed Consent Form that will describe the study in detail. A member of the study team will review this form with you and answer any questions you may have. If you agree to participate, a member of the study team will review your medical history with you, a physical exam will be performed along with a vital signs check, and blood & urine collection. The duration the screening visit is about 2.5 hours.

The test results from the screening visit will determine if you are eligible to participate in the rest of the study.

Compensation is offered to those who complete study visits. No compensation is offered for the screening visit. Specific amounts per visit may be discussed with a member of the study team at the time of your screening visit.

* If volunteer wants more specific information, please refer to study coordinator.

If volunteer agrees to Screening Visit, please assign MRN and schedule the following:

Screening Visit

Screening Visit scheduled for: _____ / _____ / _____ @ ___ ____ : ____ ____

*Please instruct volunteer to fast (nothing but water) for 10 hours prior to SCREENING VISIT ONLY.

*Please instruct volunteer to bring all medications (prescription and over the counter), herbal supplements, vitamins, home remedies, birth control pills taken over the last 8 weeks.

_________________________________________ _____ / _____ / _____

Phone Screening Staff Printed Name / Signature	Date