NCT00538720

Brief Summary

The goal of this clinical research study is to learn how the standard practice of giving Vitamin D supplements to patients with a Vitamin D deficiency may affect the size of the parathyroid glands in patients with PHPT and a Vitamin D deficiency.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2007

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

10.7 years

First QC Date

October 2, 2007

Last Update Submit

March 21, 2019

Conditions

Hyperparathyroidism

Keywords

Primary HyperparathyroidismPHPTParathyroid glandsVitamin D deficiencyVitamin DErgocalciferol

Outcome Measures

Primary Outcomes (1)

  • Size of parathyroid glands

    Size of individual gland recorded while only the gland with maximum size at baseline included for analysis of primary endpoint. With sample size of 22, a two-sided 95% confidence interval for mean changes in size of parathyroid glands will extend 2.09 from observed mean, assuming that standard deviation is known to be 5 and confidence interval is based on the z statistic. Parameters for parathyroid glands compared pre- and post-replacement on an individual, gland-by-gland basis.

    Baseline to 3-months post treatment

Study Arms (1)

Vitamin D

EXPERIMENTAL

Vitamin D starting dose 50,000 IU by mouth 3 times weekly for three weeks (+/- one week), then 50,000 IU twice weekly for 6 weeks (+/- one week).

Drug: Vitamin DDevice: Four-dimensional computed tomography (4DCT)

Interventions

Vitamin DDRUG

Starting dose 50,000 IU by mouth 3 times weekly for three weeks (+/- one week), then 50,000 IU twice weekly for 6 weeks (+/- one week).

Also known as: Ergocalciferol
Vitamin D
Four-dimensional computed tomography (4DCT)DEVICE

Four-dimensional computed tomography (4DCT) scan of the neck.

Also known as: 4DCT, 4-D Computed Tomography
Vitamin D

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be diagnosed with PHPT (inappropriate PTH level in the setting of a high or high-normal corrected serum calcium level equal to or greater than 10.0 mg/dL)
  • Be considered an appropriate surgical candidate
  • Be older than 21 years of age
  • Have a vitamin D (25-OHD) level less than or equal to 20ng/ml
  • Female participants of childbearing potential must have a negative pregnancy test (urinary or serum beta-HCG) within two weeks before signing consent

You may not qualify if:

  • Have any other functional tumors if they have familial multiple endocrine neoplasia syndrome 1 or 2 (MEN 1 or MEN 2)
  • Have a corrected calcium level greater than 13mg/dL
  • Have a recent history of kidney stones
  • Have a recent history of pancreatitis
  • Have a recent history of cardiac arrhythmia (eg atrial fibrillation)
  • Unable to keep still for 2 minutes without coughing
  • Having a body habitus that prevents adequate images to be obtained through the region of the parathyroids (ie typically weighing in excess of 250Lbs)
  • Have a serum creatinine greater than 2.0 mg/dl
  • Have hypersensitivity to ergocalciferol or any component of the formulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

HyperparathyroidismHyperparathyroidism, PrimaryVitamin D Deficiency

Interventions

Vitamin DErgocalciferolsFour-Dimensional Computed Tomography

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipidsTomography, X-Ray ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImaging, Three-DimensionalRadiographic Image EnhancementRadiographyTomography, X-RayTomography

Study Officials

  • Nancy D. Perrier, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2007

First Posted

October 3, 2007

Study Start

October 1, 2007

Primary Completion

May 30, 2018

Study Completion

May 30, 2018

Last Updated

March 25, 2019

Record last verified: 2019-03

Locations

US(1)