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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.



            References


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