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.

• N = 113   
• AGE: Mean = 60.9 years (SD = 8.8)
• FEMALES: 100%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Breast cancer receiving aromatase inhibitors and experiencing AIMSS
• OTHER KEY SAMPLE CHARACTERISTICS: Patients had been on AI treatment an average of 19.9 months, and 54% had prior chemotherapy.

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Minnesota

PHASE OF CARE: Late effects and survivorship

Double-blind RCT

• Australian/Canadian osteoarthritis hand index
• Western Ontario and McMaster osteoarthritis index (WOMAC)
• Breast cancer trial symptom scale-musculoskeletal subscale (BCPT-MS)
• Handgrip strength
• Serum hormone and 25(OH)D levels
• Use of analgesics

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.