CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 82 enrolled
Drug / intervention
Tums +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03869398
NCT03869398N/ACompleted

Does Preoperative Calcium and Calcitriol Decrease Rates of Post Thyroidectomy Hypocalcemia?

Lahey Clinic·interventional·Posted Mar 11, 2019·Updated Jul 9, 2019

In Brief

A clinical study evaluating Tums and Calcitriol for Hypocalcemia and Thyroid Diseases. Completed, enrolled 82 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 11, 2019
Enrollment StartAug 1, 2017
Primary CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.3 years ago

Interventions

Tumsdietary

start their calcitriol 0.25mcg PO BID and Tums 1,500mg PO TID 5 days before surgery. The five days is determined due to the time it takes vitamin D to have an effect on the guts reabsorption of calcium.

Calcitrioldietary

start their calcitriol 0.25mcg PO BID and Tums 1,500mg PO TID 5 days before surgery. The five days is determined due to the time it takes vitamin D to have an effect on the guts reabsorption of calcium.