Correlation of symptoms with vitamin D deficiency and symptom response to cholecalciferol treatment: a randomized controlled trial.
OBJECTIVE
To examine the association of symptoms with vitamin D deficiency and symptom response to cholecalciferol treatment in a randomized, double-blind, placebo-controlled trial.


METHODS
Adult primary care patients in Duluth, Minnesota, were screened for vitamin D deficiency in February 2007. Participants completed questionnaires pertaining to a variety of symptoms, vitamin D intake, and selected medical conditions. Patients with mild to moderate vitamin D deficiency (25-hydroxyvitamin D [25(OH)D], 10-25 ng/mL) participated in a randomized controlled trial (RCT) of vitamin D replacement and its effect on symptoms. Participants were randomly assigned to receive 50 000 units of cholecalciferol (vitamin D3) weekly or placebo for 8 weeks. Patients with severe vitamin D deficiency (25[OH]D <10 ng/mL) were treated in an unblinded fashion, and symptoms were reevaluated post treatment.


RESULTS
A total of 610 patients underwent initial screening, and 100 patients with mild to moderate vitamin D deficiency participated in the RCT. Thirty-eight severely deficient patients were treated in an unblinded fashion. On initial screening, 46.2% of participants were deficient in vitamin D. Self-reported vitamin D supplementation, milk intake, celiac disease, gastric bypass, and chronic pancreatitis were predictive of vitamin D status. Severely deficient participants reported increased musculoskeletal symptoms, depression (including seasonal), and higher (worse) scores on a fibromyalgia assessment questionnaire. In the RCT, the treated group showed significant improvement in fibromyalgia assessment scores (P = 0.03), whereas the placebo-treated participants did not. Severely deficient patients did not show symptom improvement over the 8-week trial period or when followed up 1 year later.


CONCLUSIONS
Compared with participants in the placebo group, patients in the treatment group showed mild short-term improvement in the overall fibromyalgia impact score, but did not show significant improvement in most musculoskeletal symptoms or in activities of daily living.
Arvold
David S
DS
St Luke's Internal Medicine Associates, Duluth, Minnesota 55802, USA. DArvold@slhduluth.com
Odean
Marilyn J
MJ
Dornfeld
Maude P
MP
Regal
Ronald R
RR
Arvold
Judith G
JG
Karwoski
Gene C
GC
Mast
David J
DJ
Sanford
Paul B
PB
Sjoberg
Robert J
RJ
D000328:Adult; D000368:Aged; D000465:Algorithms; D054316:Biomarkers, Pharmacological / Q000032:analysis*; D002112:Calcifediol / Q000097:blood; D002762:Cholecalciferol / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011379:Prognosis; D012307:Risk Factors; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014808:Vitamin D Deficiency / Q000097:blood / Q000175:diagnosis* / Q000188:drug therapy* / Q000209:etiology
D054316:Biomarkers, Pharmacological; D010919:Placebos; D002762:Cholecalciferol; D002112:Calcifediol