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8 Vitamin D and Cancer Chemoprevention 187
that p21 significantly increased by 242% in the vitamin D alone and calcium alone
groups. The combined treatment group showed a non-significant increase of 25%.
There were no significant changes in MIB-1 or hTERT markers. Bax increased signifi-
cantly by 56% along the full length of the crypts (p = 0.02) in the vitamin D alone group
and not significantly in the other two intervention groups. The changes in Bax expres-
sion were seen predominantly in the differentiation zone of the crypts while Bcl-2 did
not change throughout treatment.
8.3.3 On-going Clinical Trials
Three additional studies, supported by NIH funding are currently underway. The
VITAL trial (PI: JE Manson) will enroll 20,000 men and women and is designed to
test in a randomized, factorial study the independent and combined effects of vita-
min D (1,600 IU/D) and omega-3 fatty acids (1 g/D) on cancer and cardiovascular
endpoints. Another study, which is using oral calcitriol (1,25 dihydroxycholecalcif-
erol) to prevent the recurrence and progression of premalignant bronchoepithelial
lesions in high risk lung cancer patients (PI: ME Reid). Finally, topical vitamin D
is being tested for the prevention of basal cell carcinoma (BCC) in a pilot study of
high risk skin cancer patients.
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