Hypocalcemia Clinical Trial
Official title:
Correction of Vitamin D Deficiency to Prevent Postoperative Hypocalcemia After Thyroidectomy
Hypocalcemia is a frequent adverse event after thyroidectomy. It is usually related to hypoparathyroidism, but preoperative hypocalcemia, hypomagnesemia or vitamin D deficiency contributes to it. This study aims to determine the frequency of vitamin D deficiency or insufficiency in patients submitted to thyroidectomy, to define the risk attributed to vitamin D deficiency to postoperative hypocalcemia, to identify other factors associated to postoperative calcium disorder, and to evaluate the benefit of preoperative treatment of vitamin D deficiency to prevent postoperative hypocalcemia.
Subjects to be submitted to total thyroidectomy will be included in the study. The investigators will evaluate serum levels of total calcium, ionic calcium, phosphorus, magnesium, creatinine, albumin, alkaline phosphatase, fasting glucose, thyroid stimulating hormone (TSH), free thyroxin (FT4), intact parathyroid hormone (PTH), 25 hydroxy vitamin D (25OHD), osteocalcin, C-terminal telopeptide (CTX) and procollagen type 1 amino-terminal propeptide (P1NP). Patients will be randomized to 3 groups: (1) 30 subjects with 25OHD < 20 ng/mL that will receive 100,000U of cholecalciferol weekly for 4 weeks before surgery, (2) 30 subjects with 25OHD < 20 ng/mL that will not receive cholecalciferol before surgery and (3) 30 controls with 25OHD >= 20 ng/mL that will not receive cholecalciferol before surgery. Afterwards, the investigators will evaluate immediate postoperative PTH and measure serum levels of total calcium, ionic calcium, magnesium, alkaline phosphatase, osteocalcin, CTX and P1NP in first and second postoperative days for further analysis. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02892253 -
Parathyroid Autofluorescence Visualization in Thyroid Surgery: Impact on Postoperative Hypocalcemia
|
N/A | |
Completed |
NCT05043584 -
Near-infrared Autofluorescence (NIRAF)-Guided Total Thyroidectomy: Impact in Low-volume, Non-parathyroid Institutions
|
N/A | |
Recruiting |
NCT05885256 -
Clinical Assessment of Low Calcium In traUMa (CALCIUM)
|
||
Recruiting |
NCT04160637 -
Is There Benefit From Early Postoperative PTH Monitoring?
|
||
Completed |
NCT00506103 -
The No-Tie Technique Using the Harmonic Scalpel in Total Thyroidectomy With Central Neck Dissection: A Prospective Randomized Study
|
N/A | |
Recruiting |
NCT05585593 -
Registry for Hypoparathyroidism Wuerzburg
|
||
Recruiting |
NCT04012476 -
Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy
|
Phase 4 | |
Recruiting |
NCT05586529 -
Effect of Preoperative High-dose Cholecalciferol in Prevention of Post-thyroidectomy Hypocalcaemia
|
N/A | |
Completed |
NCT01868750 -
Phase II Pre-operative Vitamin D Supplementation to Prevent Post-thyroidectomy Hypocalcemia
|
Phase 2 | |
Completed |
NCT00668200 -
Impact on Reducing the Incidence of Low Serum Calcium by Providing Educational Materials on the Need to Take Daily Supplemental Calcium and Vitamin D to Patients With Paget's Disease Treated With Reclast®
|
Phase 4 | |
Terminated |
NCT00623974 -
Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia
|
Phase 2 | |
Completed |
NCT00630214 -
Prevention of Hypocalcemia in Patients Undergoing Total Thyroidectomy Plus Central Neck Dissection
|
Phase 2 | |
Not yet recruiting |
NCT03685877 -
Hypocalcemia in Infants and Children
|
||
Terminated |
NCT00001151 -
Studies With 1,25-Dihydroxycholecalciferol
|
Phase 2 | |
Completed |
NCT04750460 -
Injection of Teriparatide to Prevent Hypocalcemia After Parathyroidectomy in Dialysis Patients (TeriCa).
|
Phase 3 | |
Not yet recruiting |
NCT03063060 -
The Impact of Vitamin D Deficiency on Hypocalcaemia Following Total Thyroidectomy
|
N/A | |
Not yet recruiting |
NCT04304573 -
Is Correcting Total Serum Calcium Levels Important After Thyroidectomy
|
||
Recruiting |
NCT05216419 -
Prevention of Postoperative Hypocalcemia of Oral Vitamin D Supplementation Before Total Thyroidectomy
|
Phase 4 | |
Recruiting |
NCT04775381 -
Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation
|
Phase 3 | |
Recruiting |
NCT05260255 -
Effect of Vitamin D Supplement on Disease Activity in SLE
|
N/A |