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NCT03869398 · ClinicalTrials.gov registry record · NA
Does Preoperative Calcium and Calcitriol Decrease Rates of Post Thyroidectomy Hypocalcemia?
A NA study, sponsored by Lahey Clinic.
- Completed
- Registry status
- NA
- Development phase
- 82
- Enrollment target
NCT03869398: Completed NA study, sponsored by Lahey Clinic.
NCT03869398 is a NA study that has completed, run by Lahey Clinic. The registered enrollment target is 82 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03869398, a NA study, has completed, sponsored by Lahey Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 82 participants
- Enrollment target
Study Summary
The investigators are performing this study to determine if supplementation with calcium and calcitriol (vitamin D) before surgery decreases the rate of hypocalcemia (low calcium) after surgery. Postoperative hypocalcemia (low calcium) is the most common complication after thyroidectomy. Symptoms range from numbness/tingling around the mouth and fingers to severe problems such as low blood pressure, irregular heartbeat, muscle cramps and uncontrollable muscle spasms. The current standard of practice at Lahey for patients undergoing total thyroidectomy is to start Tums 1500mg three times daily and Calcitriol 0.25mcg twice daily immediately after surgery. Also current practice is for each patient to have their calcium and albumin levels checked at 8 hours and 24 hours after surgery. If the corrected calcium level drops below 8.5 or they exhibit symptoms of hypocalcemia the dose of the Tums and Calcitriol are increased per protocol. All patients must also follow up in 3-4 days to have their calcium and albumin levels rechecked. The investigators propose to change the above standard practice at Lahey by making only one change. The investigators wish to start Tums and Calcitriol 5 days before surgery, as opposed to after surgery. This will be the only change to the current standard of care at Lahey. The investigators hypothesize that initiating Tums and Calcitriol supplementation in the preoperative period will decrease the overall rate of postoperative hypocalcemia and its related symptoms. This will possibly decrease length of hospital stay, decrease cost, and prevent any serious complications associated with low calcium.
Primary Outcome
The main objective of this study is to determine if treating patients with calcitriol and calcium prior to thyroidectomy decreases postoperative hypocalcemia. The primary outcome to be measured is clinical hypocalcemia, defined as peri-oral numbness and/or tingling, numbness and/or tingling in fingers, tetany, seizures, hypotension, palpitations
Interventions
- DIETARY_SUPPLEMENT Calcitriol
- DIETARY_SUPPLEMENT Tums
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2017-08-01 |
| Est. Completion | 2019-07-01 |
| Phase | NA |
What the finished NCT03869398 record still lists
NCT03869398 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Calcitriol is the first listed.
NCT03869398 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03869398 about?
NCT03869398 is a clinical study titled "Does Preoperative Calcium and Calcitriol Decrease Rates of Post Thyroidectomy Hypocalcemia?". The investigators are performing this study to determine if supplementation with calcium and calcitriol (vitamin D) before surgery decreases the rate of hypocalcemia (low calcium) after surgery. Postoperative hypocalcemia (low calcium) is the most common complication after thyroidectomy. Symptoms r...
What is the current status of trial NCT03869398?
This trial is currently completed. It is a NA study. The enrollment target is 82 participants. The study started on 2017-08-01. Estimated completion is 2019-07-01.
What interventions are being tested in trial NCT03869398?
The interventions under investigation include: Calcitriol (DIETARY_SUPPLEMENT), Tums (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03869398?
This trial is sponsored by Lahey Clinic, which has 43 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03869398's enrollment target sits among peer trials
82 990th of 2000 higher than 1,009 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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