| Eligibility |
Inclusion Criteria:
1. Subject has voluntarily signed and dated an informed consent form (ICF), approved by
an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), and provided
Health Insurance Portability and Accountability Act (HIPAA) (or other applicable
privacy regulation) authorization prior to any participation in the study.
2. Subject is male or female and is = 65 and = 85 years of age.
3. Subject has Body Mass Index (BMI) = 20 but = 32 kg/m2.
4. Subject is ambulatory and able to walk = 25 meters without the use of an assistive
device.
5. Subject has a serum 25-hydroxyvitamin D level = 7.5 but = 22.5 ng/ml (18.75 to 56.25
nmol/L) at screening.
6. Subject agrees to apply sunscreen (= SPF 30) on any exposed skin, when expecting an
increase in exposure to sunlight (e.g. a planned holiday of more than eight days, a
beach holiday or a holiday in the southern hemisphere, for the duration of the study).
7. Subject agrees not to use tanning beds for the duration of the study.
8. Subject agrees to refrain from starting any new exercise program, or weight loss
program, for the duration of the study.
9. Subject is able to follow the protocol.
Exclusion Criteria:
1. Subject states they regularly consume supplemental vitamin D in the amount greater
than the age-specific Institute Of Medicine daily recommended dietary allowance (600
IU or 15 µg for a subject = 65 to = 70 years of age; 800 IU or 20 µg for a subject >
70 years of age). Supplemental vitamin D includes standalone vitamin D supplements,
vitamin D supplements with calcium, multi-vitamins, any medications containing vitamin
D, and purposefully seeking sunlight when outdoors.
2. Subject states they have received vitamin D3 by injection within the last 3 months.
3. Subject is missing, or has had an amputation of, a limb.
4. For a subject who reports > 2 falls within the last year, or one fall within the last
year with injury, study physician and study PI must approve participation in the
study.
5. Subject states they have an abnormality or obstruction of the gastrointestinal tract
precluding swallowing (e.g. dysphagia) and digestion (e.g., known intestinal
malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis,
steatorrhea).
6. Subject states they have sarcoidosis, lymphoma, primary hyperparathyroidism, or any
other disease that may enhance serum calcium concentration, as determined by the study
physician.
7. Subject states they have had kidney stones within the last 3 years.
8. Subject states they have abnormal indices of calcium metabolism including
hypercalcemia.
9. Subject states they have a granulomatous disease such as sarcoidosis, active chronic
tuberculosis, and Wegener's granulomatosis.
10. Subject states they have been diagnosed with renal failure, renal insufficiency, or
chronic kidney disease, or has received hemodialysis.
11. Subject states they have an active malignant disease, except basal or squamous cell
skin carcinoma or carcinoma in situ of the uterine cervix.
12. Subject states they have liver failure (decompensated chronic liver disease).
13. Subject has a stated history of a significant cardiovascular event (e.g., myocardial
infarction, heart failure, or stroke) = 3 months prior to screening visit.
14. Subject states they are currently diagnosed with, or has a history of severe dementia
or delirium, eating disorder, history of significant neurological or psychiatric
disorder, alcoholism, substance abuse or other conditions that may interfere with
study dietary supplement consumption or compliance with study protocol procedures in
the opinion of the principal investigator or study physician.
15. Subject reports having undergone major surgery, less than 6 weeks prior to enrollment
in the study, or subject has planned inpatient surgery requiring 2 or more days of
hospitalization during the entire study.
16. Subject states they have undergone hip replacement surgery within the last year.
17. Subject states they are currently being prescribed (by primary care physician or other
health professional) medication that in the opinion of the study physician will have
an effect on serum 25-hydroxyvitamin D levels (e.g., certain anticonvulsants,
phenobarbital, carbamazepine, phenytoin).
18. Subject states they have been undergoing treatment within the last 2 years for
epilepsy, and the treatment has an effect on serum 25-hydroxyvitamin D.
19. Subject states they have been prescribed within the last 2 years bisphosphonates or
parathyroid hormone.
20. Subject states they cannot refrain from anabolic hormones or growth hormone, starting
at screening and over the entire course of the study.
21. Subject reports alcohol intake as average of 3 or more servings per day (a serving
defined as 4 oz wine, 12 oz beer, 1 oz spirits).
22. Subject states they have an allergy or intolerance to any ingredient in the study
product.
23. Subject is deemed unsuitable for study based upon study physician assessment.
24. Subject is taking part in another clinical trial.
25. The use of fat absorption inhibiting products (e.g., prescription orlistat (Xenical),
over the counter orlistat (Alli)) during the study.
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