This trial is novel for a number of reasons; namely, treatment was done daily (vs weekly), using cholecalciferol or vitamin D3 (vs vitamin D2), and dosing was based on deficiency levels and provided at 1200 to 2400 IU/day. Additionally, treatment had a goal of increasing levels to > 32 ng/mL (the ending level of a previous negative study) and was continued for a longer period of time (20 weeks) than in previous trials. By the end of 3 months, the treatment group had gone from an average of 20 ng/ml to almost 50 ng/ml and reduced severity of pain during the preceding 7 days by approximately 20 points (on a 0–100 scale). This trial followed patients after discontinuation and noted that, by week 49, levels had dropped to 26 ng/ml and pain reduction was reduced by a third. There were no significant changes in other areas between groups, including FIQ and mood scores, although the starting severity of these patients (based on baseline FIQ) was noted to be less severe than average. Lastly, 2 patients did not have elevation of their vitamin D levels, even with supplementation.

Making sense of the trial

This trial, although small, deserves attention because it is one of the first to increase vitamin D to nearly 50 ng/ml (with levels > 40 ng/ml noted as important for deriving some of vitamin D’s benefits) and did so without significant adverse effects.^1,2 The trial also noted that discontinuation for approximately 6 months created a return to insufficiency as well as loss of one-third of the pain relief. Additionally, the pain relief did not significantly equate with improvement in other areas, such as depression or anxiety.

These findings that note a small but meaningful benefit in pain in fibromyalgia but not the overall burden of the disease make sense. First, we realize that fibromyalgia is a complex disorder associated with a number of areas of potential deficiencies, such as coenzyme Q10, as related to mitochondrial dysfunction, which may require treatment.³ Similarly, vitamin D is a pluripotent compound that acts on areas such as gene transcription and may work in a nonlinear manner (ie, not in a dose–response manner), thus creating the scenario that patients may benefit at dissimilar doses.

Bottom line

It appears worthwhile to improve vitamin D levels in fibromyalgia patients with deficient or insufficient concentrations to 40 to 60 ng/ml for several months while monitoring pain and 25-hydroxy vitamin D levels. Some patients will not have an increase in levels and will require evaluation for secondary causes of deficiency.

• References

  1. Bischoff-Ferrari HA, Giovannucci E, Willett WC, et al. Estimation of optimal serum concentrations of 25-hydroxyvitamin D for multiple health outcomes. Am J Clin Nutr. 2006;84(1):18–28.
  2. Garland CF, Gorham ED, Mohr SB, Garland FC. Vitamin D for cancer prevention: global perspective. Ann Epidemiol. 2009;19(7):468–483.
  3. Cordero MD, De Miguel M, Mareno-Fernandez AM, et al. Mitochondrial dysfunction and mitophagy activation in blood mononuclear cells of fibromyalgia patients: implication in the pathogenesis of the disease. Arthritis Res Ther. 2010;12(1):R I7.

• Related Items

  1. Effects of Vitamin D on Pain From Fibromyalgia