Vitamin D Repletion in Primary Hyperparathyroidism

NCT01306656 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: AAAF1797R01DK084986-05
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Hyperparathyroidism; Vitamin D Deficiency

Keywords

Endocrinology; Metabolic Bone Disease; Primary Hyperparathyroidism; PHPT; Vitamin D Deficiency; Bone Mineral Density; Hyper-calcemia

Outcome Measures

Primary Outcomes (1)

• Serum Parathyroid Hormone (PTH) Level

  This is designed to measure how many participants will achieve PTH \> 65 pg/mL.

  6 months

Secondary Outcomes (3)

• Areal Bone Mineral Density of the Lumbar Spine

  6 months

• Trabecular Bone Density at the Forearm

  6 months

• Change in Urinary Calcium Level

  1 month, 3 months, 6 months

Study Arms (2)

Group 1

EXPERIMENTAL

10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D

Drug: 10,000 IU Vitamin D3; Dietary Supplement: Vitamin D

Group 2

PLACEBO COMPARATOR

Placebo plus a multivitamin with 400 IU vitamin D

Other: Placebo; Dietary Supplement: Vitamin D

Interventions

10,000 IU Vitamin D3 DRUG

Month 1: 20,000 IU vitamin D3 once a week Months 2-6: 10,000 IU vitamin D3 once a week

Also known as: Cholecalciferol-D3

Group 1

Placebo OTHER

Month 1: Placebo once a week Months 2-6: Placebo once a week

Also known as: Placebo pill

Group 2

Vitamin D DIETARY_SUPPLEMENT

Daily multivitamin with 400 IU vitamin D.

Also known as: cholecalciferol

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Hyperparathyroidism, Primary; Vitamin D Deficiency; Bone Diseases, Metabolic

Interventions

Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Limitations and Caveats

Study enrollment did not reach the required number of subjects; the analysis results would not have been reliable or have enough statistical power. Therefore, samples were not processed and data was not analyzed.

Results Point of Contact

• Title: Shonni Silverberg, MD
• Organization: Columbia University

sjs7@cumc.columbia.edu

212-305-6291

Study Officials

• Shonni J Silverberg, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patient, investigator and study team will be blinded to study arm ramdomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Active arm: Month 1: 20,000 IU vitamin D3 once a week, plus daily multivitamin with 400 IU vitamin D. Months 2-6: 10,000 IU vitamin D3 once a week, plus daily multivitamin with 400 IU vitamin D. Placebo arm: Month 1: Placebo once a week plus daily multivitamin with 400 IU vitamin D. Months 2-6: Placebo every week plus daily multivitamin with 400 IU vitamin D.

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: March 2, 2011
• Study Start: October 1, 2011
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: April 16, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-03

Locations

US (1)