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NCT01868750 · ClinicalTrials.gov registry record · Phase 2

Phase II Pre-operative Vitamin D Supplementation to Prevent Post-thyroidectomy Hypocalcemia

A Phase 2 study of Thyroid Nodules and Hypocalcemia, sponsored by David Shonka, MD.

Completed
Registry status
Phase 2
Development phase
67
Enrollment target
1
Study location

NCT01868750: Completed Phase 2 study of Thyroid Nodules and Hypocalcemia, sponsored by David Shonka, MD.

NCT01868750 is a Phase 2 study of Thyroid Nodules and Hypocalcemia that has completed, run by David Shonka, MD. The registered enrollment target is 67 participants, below the 161-participant average among 3 other Thyroid Nodules trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01868750, a Phase 2 study of Thyroid Nodules and Hypocalcemia, has completed, sponsored by David Shonka, MD.

COMPLETED
Registry status
Phase 2
Development phase
67 participants
Enrollment target
1
Study location

Study Summary

One of the major side effects of surgery to remove the thyroid gland is transient (lasting for a short time) low calcium levels in the blood, or "hypocalcemia." Low calcium levels can cause symptoms such as numbness around the mouth, tingling or cramping in the hands and feet, severe muscle spasms, inability to breathe, or heart rhythm (heart beat) abnormalities. Severe symptoms are life threatening, so it is important to start the management of these symptoms in the hospital. Treating low calcium levels sometimes require patients to spend a few extra days in the hospital. The human body needs vitamin D to function and stay healthy. Vitamin D helps the body get the calcium needed to make strong bones and teeth. The purpose of this study is to determine if taking vitamin D before surgery to remove the thyroid gland affects whether or not you may have low calcium levels after your surgery and to test the hypothesis that those who are given the Vitamin D before surgery will have decreased hypocalcemia and a shortened hospital stay.

Primary Outcome

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

Conditions Studied

Thyroid Nodules Hypocalcemia

Interventions

  • DIETARY_SUPPLEMENT Calcitriol
  • DIETARY_SUPPLEMENT Control Pill

Study Locations (1)

Virginia

  • University of Virginia - Charlottesville

Trial Details

FieldValue
Enrollment Target 67 participants
Start Date 2013-05
Est. Completion 2021-07-08
Phase Phase 2
David Shonka, MD

1 total trials

What the finished NCT01868750 record still lists

NCT01868750 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 161-participant average among 3 other Thyroid Nodules trials with a reported enrollment target (58% lower).

The record links to 2 conditions, with Thyroid Nodules appearing as the primary indexed condition, and to 2 interventions - of which Calcitriol is the first listed.

NCT01868750 reports a single indexed study location in Virginia.

Frequently Asked Questions

What is clinical trial NCT01868750 about?

NCT01868750 is a clinical study titled "Phase II Pre-operative Vitamin D Supplementation to Prevent Post-thyroidectomy Hypocalcemia". One of the major side effects of surgery to remove the thyroid gland is transient (lasting for a short time) low calcium levels in the blood, or "hypocalcemia." Low calcium levels can cause symptoms such as numbness around the mouth, tingling or cramping in the hands and feet, severe muscle spasms, ...

What is the current status of trial NCT01868750?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2013-05. Estimated completion is 2021-07-08.

What conditions does trial NCT01868750 study?

This clinical trial studies the following conditions: Thyroid Nodules, Hypocalcemia.

What interventions are being tested in trial NCT01868750?

The interventions under investigation include: Calcitriol (DIETARY_SUPPLEMENT), Control Pill (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01868750?

This trial is sponsored by David Shonka, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01868750 being conducted?

This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT01868750, the US trial registry maintained by the National Library of Medicine. NCT01868750 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.