Phase 3 N=46 Randomized Quadruple-blind Treatment

Effect of Vitamin D Treatment in Primary Hyperparathyroidism

Vitamin D Deficiency · Primary Hyperparathyroidism · Hypercalcemia

Bottom Line

View on ClinicalTrials.gov: NCT00674154 ↗

Enrolled (actual)

Serious AEs

4.8%

Results posted

Oct 2013

Primary outcome: Primary: Decrease in Preoperative P-PTH — -2.2; 0.2 pmol/l

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Cholecalciferol (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Aarhus
Primary completion: Aug 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Decrease in Preoperative P-PTH	-2.2; 0.2	—
SECONDARY Improved Muscular Function	—	—
SECONDARY Reduced Postoperative Hypocalcemia	—	—
SECONDARY Increase in Quality of Life	—	—
SECONDARY Increased Bone Mineral Density	—	—
SECONDARY Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm	—	—

Summary

The primary aim of the study is to assess whether 6-months of vitamin D supplements can decrease PTH compared with placebo treatment in primary hyperparathyroidism.

Eligibility Criteria

Inclusion Criteria

P-Ca-ion > 1,30 mmol/l
P-PTH > 5 pmol/l
P-OH25-vitamin D 120 mumol/l
usage of Etalpha, Mimpara
Cancer
Sarcoidosis
malabsorption
pancreatitis
alcohol abuse
pregnancy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00674154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.