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Vitamin D Repletion in Primary Hyperparathyroidism

NCT01306656 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-04-16

Study results available
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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

Interventions

DRUG

10,000 IU Vitamin D3

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

OTHER

Placebo

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

DIETARY_SUPPLEMENT

Vitamin D

Daily multivitamin with 400 IU vitamin D.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Shonni J Silverberg, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2017-02-28
Completion
2017-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01306656 on ClinicalTrials.gov