Phase 4
N=9
Vitamin D Repletion in Primary Hyperparathyroidism
Primary Hyperparathyroidism · Vitamin D Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT01306656 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Serum Parathyroid Hormone (PTH) Level
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 10,000 IU Vitamin D3 (Drug); Placebo (Other); Vitamin D (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Parathyroid Hormone (PTH) Level |
— | — |
| SECONDARY Areal Bone Mineral Density of the Lumbar Spine |
-.98777; 1.442861 | — |
| SECONDARY Trabecular Bone Density at the Forearm |
-1.00345; -2.59816 | — |
| SECONDARY Change in Urinary Calcium Level |
182.67; 154; 172.67; 115.5; 195.17; 50.5 | — |
Summary
This study will look at the effect of 2 treatment regimens that contain vitamin D in a six-month treatment trial of patients with PHPT who are vitamin D deficient. Patients will be assigned randomly to one of 2 regimens, and will be followed with tests of their blood, urine and bones. This study should provide important information on the effect of vitamin D therapy in patients with PHPT. In addition, data from this study will guide physicians as to how best to treat their patients who have PHPT and vitamin D deficiency.
Eligibility Criteria
Inclusion Criteria
- Diagnosed PHPT, defined by an elevated serum calcium level (we will not study normocalcemic PHPT) with elevated or inappropriately normal PTH levels.
- Vitamin D3 less than 30 ng/ml
Exclusion Criteria
- Patients with familial hyperparathyroid syndromes
- Current or past use of the following medications: bisphosphonate within past 2 years, use of lithium or thiazide diuretics, current use of cinacalcet, use of aluminum containing medications, cimetidine, colestipol, or orlistat
- Malignancy, except cured basal or squamous cell skin carcinoma or other cured cancers that are at least five years free from recurrence
- History or current diagnosis of certain medical diseases (including sarcoidosis, active infectious granulomatous disease, HIV/AIDS, chronic kidney disease (serum creatinine > 1.5 mg/dL), liver disease; GI diseases known to affect calcium metabolism; secondary hyperparathyroidism);
- We will also exclude patients with calcium above 11.5 mg/dL, urine calcium above 350 mg/day, and active nephrolithiasis because vitamin D repletion could potentially exacerbate hypercalcemia or hypercalciuria
- Other exclusions include protected individuals (institutionalized), prisoners, and any other prospective participant who might not be able to give voluntary informed consent.
Data sourced from ClinicalTrials.gov (NCT01306656). 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.