Shapiro, A.C., Adlis, S.A., Robien, K., Kirstein, M.N., Liang, S., Richter, S.A., & Lerner, R.E. (2016). Randomized, blinded trial of vitamin D3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). Breast Cancer Research and Treatment, 155, 501–512.
To compare outcomes between women receiving the tolerable upper limit intake of vitamin D3 to those receiving recommended dietary allowances.
Patients were randomized to receive either usual recommended dose or 4,000 IU vitamin D3 and 1,000 mg calcium carbonate. Participants had a four-week run-in period with 600 IU to normalize serum levels, and then received treatment according to random assignment. Treatment was given for six months. Adherence was determined by pill counts at study visits and symptoms were monitored through weekly diaries.
PHASE OF CARE: Late effects and survivorship
Double-blind RCT
In the intervention group, serum total and free 25(OH)D levels increased (p < 0.0001). After six months, there were no differences in outcome measurement scores between groups.
High-dose vitamin D3 did not results in improvement in AI-related musculoskeletal symptoms.
No information on use of analgesics is provided
This study did not show an effect of high-dose vitamin D3 for musculoskeletal side effects associated with AI treatment.