The Effect Of Vitamin D On Measures Of Bone Health And Gene Expression

Vitamin D, commonly known as the sunshine vitamin, is produced in the skin from sun exposure
as well as from dietary sources. However, very few foods naturally contain vitamin D and the
amount of vitamin D in fortified foods typically, 100 IU per serving, has been totally
inadequate in satisfying adults vitamin D requirement, which is now been estimated to be at
least 2,000 IU of vitamin D a day. As a result, vitamin D deficiency is rapidly being
recognized world-wide as the most common vitamin deficiency. Upwards of 50-100% of children
and adults have been reported as being vitamin D deficient depending on ethnicity, latitude
and skin pigmentation. The investigators reported in women at the time of delivery that 76%
of mothers and 81% of newborns were vitamin D deficient despite the fact that the mother was
taking a prenatal vitamin containing 400 IU vitamin D and drinking two glasses of milk a
day. The investigators also reported 30-80% vitamin D deficiency rates in white and black
children, healthy young, middle aged and older adults. There have been numerous
epidemiologic and clinical observations relating vitamin D deficiency to many chronic
diseases and there are many isolated but no comprehensive studies evaluating various genes
that are either suppressed or enhanced by 1,25-dihydroxyvitamin D [1,25(OH)2D]. It has been
estimated that upwards of 2000 genes are directly or indirectly influence by 1,25(OH)2 D. To
date, however, there have not been any genomic signatures identified in humans in response
to correction of vitamin D deficiency. The goal of this pilot study is to determine whether
or not vitamin D3 supplementation will affect biomarkers for calcium and bone metabolism,
and how they alter gene expression biomarkers, especially genes related to the non-skeletal
actions of vitamin D.

Inclusion Criteria:

- Male and female adults of all races ages 18 years and older

Exclusion Criteria:

- 1. Pregnant and lactating women.

2. Current or recent history of hepatic or renal disease

3. History of taking a daily supplement that contains more than 400 IU vitamin D2 or
vitamin D3 within the past month or taking a pharmacologic amount of vitamin D2 or
one of the active vitamin D analogs including Zemplar (Paricalcitol), Dovonex
(calcipotriol), Hectorol (vitamin D pro hormone)

4. Subjects who are taking antiseizure medications or glucocorticoids.

5. Exposure to a tanning bed or tanning on a beach for more than eight hours within
the past month.

6. Known history of elevated calcium. (> 10.5 mg% (mg/dl))

7. History of intestinal malabsorption (i.e. Cystic Fibrosis, Fat Malabsorption
Syndrome, Crohn's Disease)

8. Unwilling to consent to this trial