Thyroid NodulesPhase 2NCT01868750
Phase II Pre-operative Vitamin D Supplementation to Prevent Post-thyroidectomy Hypocalcemia
A Phase 2 study testing Calcitriol in people with Thyroid Nodules and Hypocalcemia, run by David Shonka, MD at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodules, Hypocalcemia
- What is being tested?
- Calcitriol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to 8 Jul 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient referred for thyroidectomy
- Agreement to use contraception prior to and during the study
Who cannot join
- Hypercalcemia (>10.5mg/dL)
- Chronic kidney or parathyroid disease
- Cardiac or Central Nervous System disease
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: 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
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.
- Conditions
- Thyroid Nodules, Hypocalcemia
- Being tested
- Calcitriol, Control Pill
- Medical subject headings
- Thyroid Nodule, Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcitriolDietary supplement
1.0ug twice daily for 7 days before surgery
Control PillDietary supplement
placebo pill taken twice daily for 7 days before surgery
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D (Calcitriol) | Active comparator | Calcitriol, 1.0ug twice daily for 7 days prior to surgery Receives: Dietary Supplement: Calcitriol |
| Control | Placebo comparator | Placebo pill taken twice daily for 7 days prior to surgery Receives: Dietary Supplement: Control Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Serum Calcium Levels
Serum calcium levels will be evaluated at routine intervals to identify incidences of hypocalcemia
Measured: 2-5 days after surgery
Secondary outcomes (1)
Evidence of Hypocalcemia
Measuring hypocalcemia symptoms, requirements for IV calcium, and extended hospital stay
Measured: 2-5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startMay 2013
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NodulesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Shonka, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Shonka, MD, University of Virginia
- Investigators
- David C Shonka, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868750
- Sponsor's protocol ID
- 16544
- Status last verified
- Oct 2021
- First submitted
- 30 May 2013
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01868750
- Acronym / sponsor ID
- 16544
- Conditions
- Thyroid Nodules, Hypocalcemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- David Shonka, MDUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D (Calcitriol) | Active comparator | Dietary Supplement: CalcitriolCalcitriol, 1.0ug twice daily for 7 days prior to surgery |
| Control | Placebo comparator | Dietary Supplement: Control PillPlacebo pill taken twice daily for 7 days prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient referred for thyroidectomy
- Agreement to use contraception prior to and during the study
Key exclusion criteria (4 listed)
- Hypercalcemia (>10.5mg/dL)
- Chronic kidney or parathyroid disease
- Cardiac or Central Nervous System disease
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcitriol1.0ug twice daily for 7 days before surgery | Dietary supplement | Vitamin D (Calcitriol) |
| Control Pillplacebo pill taken twice daily for 7 days before surgery | Dietary supplement | Control |
Primary outcome
Measure of Serum Calcium Levels
Time frame: 2-5 days after surgery
Serum calcium levels will be evaluated at routine intervals to identify incidences of hypocalcemia
1 secondary outcome
Evidence of Hypocalcemia
Time frame: 2-5 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C Shonka, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Calcitriol in people with Thyroid Nodules and Hypocalcemia, run by David Shonka, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of Serum Calcium Levels (time frame: 2-5 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.