A phase 2 trial exploring the effects of high-dose (10,000 IU/day) vitamin D(3) in breast cancer patients with bone metastases.
ABSTRACT Vitamin D deficiency has potential roles in breast cancer etiology and progression. Vitamin D deficiency has also been associated with increased toxicity from bisphosphonate therapy. The optimal dose of vitamin D supplementation is unknown, but daily sunlight exposure can generate the equivalent of a 10,000-IU oral dose of vitamin D(3). This study therefore aimed to assess the effect of this dose of vitamin D(3) in patients with bone metastases from breast cancer.
Patients with bone metastases treated with bisphosphonates were enrolled into this single-arm phase 2 study. Patients received 10,000 IU of vitamin D(3) and 1000 mg of calcium supplementation each day for 4 months. The effect of this treatment on palliation, bone resorption markers, calcium metabolism, and toxicity were evaluated at baseline and monthly thereafter.
Forty patients were enrolled. No significant changes in bone resorption markers were seen. Despite no change in global pain scales, there was a significant reduction in the number of sites of pain. A small but statistically significant increase in serum calcium was seen, as was a significant decrease in serum parathyroid hormone. Treatment unmasked 2 cases of primary hyperparathyroidism, but was not associated with direct toxicity.
Daily doses of 10,000 IU vitamin D(3) for 4 months appear safe in patients without comorbid conditions causing hypersensitivity to vitamin D. Treatment reduced inappropriately elevated parathyroid hormone levels, presumably caused by long-term bisphosphonate use. There did not appear to be a significant palliative benefit nor any significant change in bone resorption.
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ABSTRACT: Information on vitamin D status of Indian health care professionals is limited. Among 2,119 subjects studied, just 6 % were found to be sufficient in vitamin D status. There is urgent need of an integrated approach to detect and treat vitamin D deficiency among health care professionals to improve on-the-job productivity. Vitamin D deficiency is prevalent worldwide. India has been reported to be one of the worst affected countries. Several single-center studies from India have shown high prevalence of vitamin D deficiency. Little is known regarding the vitamin D status of Indian health care professionals. This study aimed to determine prevalence of vitamin D deficiency among health care professionals in different regions of India. In this cross-sectional, multicenter study, we enrolled 2,119 medical and paramedical personnel from 18 Indian cities. Blood samples were collected from December 2010 to March 2011 and analyzed in a central laboratory by radioimmunoassay. Vitamin D deficiency was defined as 25-hydroxyvitamin D [25(OH)D] <20 ng/mL or <50 nmol/L, insufficiency as 25(OH)D = 20-30 ng/mL or 50-75 nmol/L, and sufficiency as 25(OH)D >30 ng/mL or >75 nmol/L. Mean (±SD) age of subjects was 42.71 ± 6.8 years. Mean (±SD) 25(OH)D level was 14.35 ± 10.62 ng/mL (median 11.93 ng/mL). Seventy-nine percent of subjects were deficient, 15 % were insufficient, and just 6 % were sufficient in vitamin D status. No significant difference was found between vitamin D status in southern (25(OH)D = 13.3 ± 6.4 ng/mL) and northern (25(OH)D = 14.4 ± 8.5 ng/mL) parts of India. Our study confirms the high prevalence of vitamin D deficiency all across India in apparently healthy, middle-aged health care professionals.Archives of Osteoporosis 12/2012; 7(1-2):187-92.