Feasibility of a randomized controlled trial of vitamin D vs. placebo in women with recently diagnosed breast cancer.
Low serum vitamin D levels have been associated with poor outcomes in women diagnosed with early breast cancer. However, no randomized controlled trials (RCTs) have been performed to determine whether vitamin D supplementation might be an effective intervention in this population. We prospectively evaluated vitamin D adequacy and supplementation rates in a contemporary cross-sectional sample of breast cancer patients from 2 large urban centers and examined the feasibility of an RCT of vitamin D supplementation. Women with recently diagnosed early breast cancer were prospectively identified and recruited in Toronto and Los Angeles between March 2009 and January 2010. Anthropometric measurements, dietary, lifestyle, and medication histories were obtained by means of structured questionnaires and interviews. Tumor and treatment characteristics were abstracted from clinical records and blood samples were collected for analysis of 25-OH vitamin D. 173 eligible patients (median age 57) were enrolled. Clinical and treatment characteristics were similar between centres. 84.4 % of women reported use of vitamin D-containing supplements with median daily doses of 1,400 IU. Median 25-OH vitamin D levels were 85.5 and 98.5 nmol/L (P = 0.1), and levels of deficiency (<50 nmol/L), insufficiency (50-72 nmol/L), and adequacy (>72 nmol/L) were 3.8, 23.8, 72.5 % (Toronto) and 4.3, 20.7, 75 % (Los Angeles). 25-OH vitamin D levels were strongly correlated with vitamin D supplement use (r = 0.41, P < 0.0001). 68 % of women expressed willingness to participate in a vitamin D supplementation RCT; however, only 12.7 % of the study population met the pre-specified feasibility criteria (25-OH vitamin D <72 nmol/L, willing to participate, and taking ≤1,000 IU vitamin D supplement/day). Both vitamin D levels and supplementation rates are higher than in previous reports. While the majority of women would be willing to participate in an RCT of vitamin D supplementation, low levels of deficiency/insufficiency and high rates of supplement use would limit the feasibility of such a study.
Mount Sinai Hospital, 1284-600 University Avenue, Toronto, ON, M5G 1X5, Canada.
David W
DW
Cescon
Patricia A
PA
Ganz
Samantha
S
Beddows
Marguerite
M
Ennis
Barbara K
BK
Mills
Pamela J
PJ
Goodwin
D001943:Breast Neoplasms / Q000097:blood / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant; D019587:Dietary Supplements; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D018579:Patient Selection; D010919:Placebos; D016032:Randomized Controlled Trials as Topic; D018709:Statistics, Nonparametric; D014807:Vitamin D / Q000097:blood / Q000627:therapeutic use*; D014815:Vitamins / Q000097:blood / Q000627:therapeutic use*
D010919:Placebos; D014815:Vitamins; D014807:Vitamin D