Fibromyalgia and Vitamin D
Florian Wepner, MD
Department of Orthopedic Pain Management
Spine Unit, Center of Excellence for Orthopaedic Pain Management
Speising, Vienna, Austria
+43 1 80182 / 1487
florian.wepner@oss.at

“Effects of Vitamin D on Patients with Fibromyalgia Syndrome: A Randomized Placebo-Controlled Trial,” Pain, 2014 Feb;155(2):261-8. 49825 (4/2014)

Kirk Hamilton: Can you please share with us your educational background and current position?

Florian Wepner: I am an orthopaedic surgeon at the Orthopaedic Hospital Speising, Vienna, Austria. Nine years ago I started to work with patients suffering from severe chronic pain besides my surgical activities. In order to deal with chronic pain patients adequately, and help manage their situation with respect to their comorbidities and social situation, I was interested in becoming a psychotherapist as well and finally completed this education 3 years ago.

KH: What got you interested in studying the role of vitamin D in fibromyalgia?

FW: The senior author of the study, Prof. Friedrich and I were reading a lot about a possible role of vitamin D in chronic pain and other diseases like depression and fatigue, which also exist in patients suffering from fibromyalgia syndrome (FMS). The role of vitamin D in such patients was and still is not sufficiently examined. That’s why we started to create a study protocol for a randomized controlled trial on the topic.

KH: What is the biochemistry of vitamin D that might alter the pathophysiology of fibromyalgia?

FW: There might be a role of vitamin D in the improvement of the muscular function. But we do not know the exact physiological mechanisms behind pain and vitamin D.

KH: What was the daily dose of vitamin D used in IUs per day? How was it taken? With meals or away from meals? In a single dose or divided dose?

FW: Depending on their serum calcifediol levels, the verum group received 2400 IU (serum calcifediol levels < 24 ng/mL) or 1200 IU (serum calcifediol levels 24 to < 32ng/mL) of cholecalciferol (vitamin D3) in a single dose, daily and dissolved in a triglyceride solution for a period of 24 weeks – with or away from meals. The aim was to keep calcifediol levels between 32 and 48 ng/mL for the duration of the trial. Serum calcifediol levels were re-evaluated at week 5 and 13 so it was possible to adapt the dose of cholecalciferol.  When serum calcifediol levels reached more than 48 ng/mL, the substitution was put on hold for safety reasons.

KH: Were blood levels of vitamin D or other biochemical markers taken before, during or after the intervention? If so did they correlate with symptoms and supplementation with vitamin D?

FW: 25-Hydroxycholecalciferol levels were evaluated at the screening visit, at week 5, 13, 25 in the placebo- and the control group. Re-evaluation was performed in both groups after a further 24 weeks without vitamin D supplementation. We also evaluated other laboratory parameters (full blood count, glutamic oxaloacetic transaminase, glutamate-pyruvate transaminase, gamma-glutamyltransferase, bilirubin, alkaline phosphatase, blood urea nitrogen, creatinine, Na, K, Ca, phosphate) at these time points. During vitamin D supplementation the serum calcifediol levels were raised in the treatment group. The other parameters were not significantly influenced by the intake of vitamin D.

KH: Can you tell us about your study and the basic results?

FW: In our study, optimization of calcifediol levels in patients suffering from FMS had a positive effect on the perception of pain compared to a control group without vitamin D supplementation receiving a placebo medication. Marked reduction in pain was noted over the treatment period in the treatment group: a 2 (groups) x 4 (time points) variance analysis showed a significant group effect in visual analog scale scores. This also was correlated with scores on the physical role functioning scale of the Short Form Health Survey 36, an item to measure health-related quality of life.

KH: Were there any side effects with the vitamin D therapy? How was the patient compliance?

FW: Compliance was suprisingly good. The intake of vitamin D was confirmed with the rising of serum calcifediol levels in the treatment group. No major side effects were seen. Only one person in the treatment group had a mild hypercalcemia (2.71 mmol/L) without developing any symptoms at week 13. The study medication was interrupted, and the patient’s serum calcium levels returned immediately to the normal range.

KH: Why did you choose a serum target level of calcifediol between 32 and 48 ng/mL?

FW: We wanted to bring serum calcifediol to a high level and chose the upper level of 48 ng/ml for safety reasons. Below 32ng/ml, by definition, begins a vitamin D deficiency.

KH: Who is a candidate for vitamin D therapy? All subjects with fibromylagia? Only those with levels below 32 ng/ml? Why not recommend all fibromyalgia patients take 4000-5000 IU of vitamin D daily?

FW: Supplementation might help in patients suffering from FMS-like symptoms with low serum calcifediol levels. With our results we cannot say if supplementation helps in patients suffering from FMS without a vitamin D deficiency. We have to keep in mind that vitamin D supplementation will in most of the cases not cure FMS but may lead to an improvement in the symptoms.

KH: What percentage of these fibromyalgia subjects in this study had vitamin D levels ABOVE 32 ng/ml at the beginning of the study?

FW: I cannot give an exact answer to this question as some patients were sent to us, knowing to have low serum calcifediol levels already. We haven’t seen too many FMS patients with low normal serum calcifediol.  A reason for this could also have been that most of the patients were coincidentally included in, or right after winter time, as most of the vitamin D is produced in the skin via sun exposure. To find out how many FMS patients had low serum calcifediol levels was not the goal of the study. The aim was to bring calcifediol levels to the high end of the normal range for the duration of the trial to find out whether this has an influence on pain perception.

KH: How can the public or health professionals use this information?

FW: Vitamin D can be tried out as a co-medication or co-therapy for patients suffering from FMS with a low serum calcifediol level. It is a relatively cheap and save therapy, as long as serum calcifediol levels are controlled regularly or at least until a stable serum level can be reached independent of the sun exposure of the patient. Treatment should be done during a longer period of time (at least 5 to six month) and the serum level should be brought to the high end of the normal range.

KH: Do you have any further comments on this very interesting subject?

FW: This therapy with a low side effect profile may be considered in patients with FMS with a low serum calcifediol level. However, further studies with larger patient numbers are needed to confirm our findings.  Meanwhile in the treatment of FMS patients a wide range of therapies such as drug therapies, psychotherapy, active exercise therapy or multimodal treatment programs (functional restoration programs) might decrease the symptoms.

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