title: Vitamin D treatment in primary hyperparathyroidism: a randomized placebo controlled trial.
abstract: BACKGROUND
  Low 25-hydroxyvitamin D levels are common in patients with primary hyperparathyroidism (PHPT) and associated with higher PTH levels and hungry bone syndrome after parathyroidectomy (PTX). However, concerns have been raised about the safety of vitamin D supplementation in PHPT.
  
  
  OBJECTIVE
  We aimed to assess safety and effects on calcium homeostasis and bone metabolism of supplementation with high doses of vitamin D in PHPT patients.
  
  
  METHODS
  This was an investigator-initiated double-blind, randomized, placebo-controlled, parallel-group trial from a single center.
  
  
  METHODS
  Forty-six PHPT patients were recruited, with a mean age of 58 (range 29-77) years, and 35 (76%) were women.
  
  
  METHODS
  Intervention included daily supplementation with 70 μg (2800 IU) cholecalciferol or identical placebo for 52 weeks. Treatment was administered 26 weeks before PTX and continued for 26 weeks after PTX.
  
  
  METHODS
  PTH, calcium homeostasis, and bone metabolism were evaluated.
  
  
  RESULTS
  Preoperatively, 25-hydroxyvitamin D increased from 50 to 94 nmol/L in the treatment group and decreased from 57 to 52 nmol/L in the placebo group (P < .001). Compared with placebo, vitamin D decreased PTH significantly by 17% before PTX (P = .01), increased lumbar spine bone mineral density by 2.5% (P = .01), and decreased C-terminal β-CrossLaps by 22% (P < .005). The trabecular bone score did not change in response to treatment, but improved after PTX. Postoperatively, PTH remained lower in the cholecalciferol group compared with the placebo group (P = .04). Plasma creatinine and plasma and urinary calcium did not differ between groups.
  
  
  CONCLUSIONS
  Daily supplementation with a high vitamin D dose safely improves vitamin D status and decreases PTH in PHPT patients. The vitamin D treatment is accompanied by reduced bone resorption and improved bone mineral density before operation.
authors.affiliation: Department of Surgery P (L.Ro., P.C.), Breast and Endocrine Section, and Department of Endocrinology and Internal Medicine (L.Re., T.S., P.V., L.M.), Tage Hansens Gade, Department of Clinical Biochemistry (L.H.), Nørrebrogade, Aarhus University Hospital, 8000 Aarhus C, Denmark; and Department of Endocrinology and Clinical Institute (P.V.), Aalborg University Hospital, 9000 Aalborg, Denmark.
authors.forename: Lars
authors.initials: L
authors.lastname: Rolighed
authors.forename: Lars
authors.initials: L
authors.lastname: Rejnmark
authors.forename: Tanja
authors.initials: T
authors.lastname: Sikjaer
authors.forename: Lene
authors.initials: L
authors.lastname: Heickendorff
authors.forename: Peter
authors.initials: P
authors.lastname: Vestergaard
authors.forename: Leif
authors.initials: L
authors.lastname: Mosekilde
authors.forename: Peer
authors.initials: P
authors.lastname: Christiansen
mesh_terms: D000328:Adult; D000368:Aged; D015519:Bone Density / Q000187:drug effects; D002118:Calcium / Q000097:blood; D002762:Cholecalciferol / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006961:Hyperparathyroidism / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000097:blood; D010710:Phosphates / Q000097:blood; D010919:Placebos; D014807:Vitamin D / Q000031:analogs & derivatives / Q000097:blood
chemical_list: D010281:Parathyroid Hormone; D010710:Phosphates; D010919:Placebos; D014807:Vitamin D; D002762:Cholecalciferol; C104450:25-hydroxyvitamin D; D002118:Calcium