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A Phase 2, Placebo-controlled, Randomized Study to Evaluate the Effect of Pre-operative Vitamin D Supplementation on Hypocalcemia Following Total or Near-total Thyroidectomy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Thyroid Nodules, Hypocalcemia

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Trial Information

A Phase 2, Placebo-controlled, Randomized Study to Evaluate the Effect of Pre-operative Vitamin D Supplementation on Hypocalcemia Following Total or Near-total Thyroidectomy


Inclusion Criteria:



- Patient referred for thyroidectomy

- Agreement to use contraception prior to and during the study

Exclusion Criteria:

- Hypercalcemia (>10.5mg/dL)

- Chronic kidney or parathyroid disease

- Cardiac or Central Nervous System disease

- Pregnant or breastfeeding women

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Measure of Serum Calcium Levels

Outcome Description:

Serum calcium levels will be evaluated at routine intervals to identify incidences of hypocalcemia

Outcome Time Frame:

2-5 days after surgery

Safety Issue:

No

Principal Investigator

David C Shonka, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia

Authority:

United States: Food and Drug Administration

Study ID:

16544

NCT ID:

NCT01868750

Start Date:

May 2013

Completion Date:

December 2014

Related Keywords:

  • Thyroid Nodules
  • Hypocalcemia
  • Hypocalcemia
  • Thyroid Nodule

Name

Location

University of VirginiaCharlottesville, Virginia  22908