A randomized double-blind placebo-controlled study adding high dose Vitamin D to analgesic regimens in patients with musculoskeletal pain

Background: The current mode of therapy for many patients with musculoskeletal pain is unsatisfactory. Purpose: We aimed to assess the impact of adding 4000 IU of vitamin D on pain and serological parameters in patients with musculoskeletal pain. Materials and methods: This was a randomized, double-blinded and placebo-controlled study assessing the effect of 4000 IU of orally given vitamin D3 (cholecalciferol) (four gel capsules of 1000 IU, (SupHerb, Israel) vs. placebo on different parameters of pain. Eighty patients were enrolled and therapy was given for 3 months. Parameters were scored at three time points: prior to intervention, at week 6 and week 12. Visual analogue scale (VAS) scores of pain perception were recorded following 6 and 12 weeks. We also measured serum levels of leukotriene B4 (LTB4), interleukin 6 (IL-6), tumor necrosis factor alpha (TNFα) and prostaglandin E2 (PGE2) by ELISA. Results: The group receiving vitamin D achieved a statistically significant larger decline of their VAS measurement throughout the study compared with the placebo group. The need for analgesic 'rescue therapy' was significantly lower among the vitamin D-treated group. TNFα levels decreased by 54.3% in the group treated with vitamin D and increased by 16.1% in the placebo group. PGE2 decreased by39.2% in the group treated with vitamin D and increased by 16% in the placebo group. LTB4 levels decreased in both groups by 24% (p<0.05). Conclusion: Adding 4000 IU of vitamin D for patients with musculoskeletal pain may lead to a faster decline of consecutive VAS scores and to a decrease in the levels of inflammatory and pain-related cytokines.