Correlation of symptoms with vitamin D deficiency and symptom response to cholecalciferol treatment: a randomized controlled trial

• Published in: Endocrine practice Vol. 15; no. 3; pp. 203 - 212
• Main Authors: Arvold, David S, Odean, Marilyn J, Dornfeld, Maude P, Regal, Ronald R, Arvold, Judith G, Karwoski, Gene C, Mast, David J, Sanford, Paul B, Sjoberg, Robert J
• Format: Journal Article
• Language: English
• Published: United States Elsevier Limited 01.04.2009
• Subjects: Adult; Aged; Algorithms; Biomarkers, Pharmacological - analysis; Calcifediol - blood; Cholecalciferol - therapeutic use; Double-Blind Method; Female; Humans; Male; Middle Aged; Placebos; Prognosis; Risk Factors; Surveys and Questionnaires; Treatment Outcome; Vitamin D Deficiency - blood; Vitamin D Deficiency - diagnosis; Vitamin D Deficiency - drug therapy; Vitamin D Deficiency - etiology
• ISSN: 1530-891X; 1934-2403
• DOI: 10.4158/EP.15.3.203

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