A randomized phase 3 clinical trial, led by researchers at the Dana-Farber Cancer Institute in the US, was conducted in several hundred cancer centers. The addition of high-dose vitamin D3 to standard treatment for patients with untreated metastatic colorectal cancer was tested.

According to the researchers, more than 450 patients received standard chemotherapy plus bevacizumab and were randomized to high-dose or standard-dose vitamin D3.

The team found no additional side effects or toxicity from adding higher doses of vitamin D3.

However, adding high-dose vitamin D3 to standard treatment did not delay cancer progression any more than standard-dose vitamin D3 alone, according to the team's analysis after an average of 20 months of follow-up.

The team of researchers noted that a potential benefit of high doses of vitamin D3 for patients with left-sided disease (primary tumors that arise in the descending colon, sigmoid colon, or rectum) has been observed and requires further investigation.

The SOLARIS trial was inspired by previous research suggesting that higher levels of vitamin D in the blood are associated with better survival for metastatic colorectal cancer and that adding high-dose vitamin D3 to standard therapy could potentially increase progression-free survival. There may be improvement, researchers said.

However, the SOLARIS results suggest that high doses of vitamin D3 cannot be recommended for treating patients with untreated metastatic colon cancer, the team stressed.