Phase 3
Completed N=46
Effect of Vitamin D Treatment in Primary Hyperparathyroidism
Vitamin D deficiency · Primary Hyperparathyroidism · Hypercalcemia
Source: ClinicalTrials.gov NCT00674154 ↗
Enrolled (actual)
46
Serious AEs
4.8%
Results posted
Oct 2013
Primary outcomePrimary: Decrease in Preoperative P-PTH — -2.2; 0.2 pmol/l
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.
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 |
— | — |
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
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. Informational only — not medical advice.