Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation

Study Overview
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Brief Summary
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This prospective study evalue the inflence of pre operative vit D3 administration on post operative hypocalcemia in patients undergoing Total thyroidectomy

Detailed Description
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Thyroidectomy is a frequent procedure. This surgery is well known but not devoid of risks. The most common postoperative complication is transitory hypocalcemia. Some studies have reported that preoperative vitamin D deficiency (VDD) is a risk factor for hypocalcemia after total thyroidectomy (TT) in patients with non toxic multinodular goiter or graves's disease. Although the association between VVD and postoperative hypocalcemia in thyroid cancer patients undergoing TT plus central compartment neck dissection (CCND) remains unclear. This prospective study evalue the inflence of pre operative vit D3 administration on post operative hypocalcemia in patients undergoing TT.

Official Title
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Study of Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation

Conditions
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Hypocalcemia

Intervention / Treatment
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* Drug: Vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient ≥ 18 years old Patient shall be operated on for a total thyroidectomy in one time for any indication Written informed consent (IC) obtained Patients with affiliation to the social security system Exclusion Criteria: • Medical history of : Thyroid or parathyroid surgery Hyperparathyroidism Granulomatosis flare-up Hypocalcemia, hypercalcemia/ hypercalciuria, or symptom of Hypocalcemia, hypercalcemia/ hypercalciuria, not due to thyroid pathologies Chronic kidney disease grade ≥4 Severe liver failure 25OHD supplementation within last 3 months before surgery Malabsorption syndrome Known hypersensitivity to vitamin D Medical history of calcic lithiasis Pregnant women Vulnerable populations (guardianship or trusteeship) Allergies to one of the components of the fruit juice

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D<br>During preoperative visit (Month -2) patients will receive a cholecalciferol supplementation added to a fruit juice. | Drug: Vitamin D<br>* Patients will receive a cholecalciferol supplementation added to a fruit juice.<br>* Other names: Treatment;|
| No Intervention: Fruit juice<br>During preoperative visit (Month -2) patients will receive only fruit juice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the effect of pre-operative cholecalciferol supplementation on the occurrence of post-operative hypocalcemia after total thyroidectomy | Measure of the occurrence of serum and / or clinical hypocalcemia. Serum hypocalcemia is defined by a level of calcemia, corrected for albuminemia, of less than 2.00 mmol / L. Clinical hypocalcemia is defined by the appearance of one of the following signs: sign of Chvostek, sign of Trousseau, paresthesias of the extremities and perioral between surgery and day 15 | At Day 15 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of clinical course in both Arm | Clinical course will be measured, for several items, and compared between both groups to see if a significant difference is observed. Items, considered for comparison, are listed below : Initial hospital stay (number of days), number of readmission, adverse event (number) | At 3 month | 
| Comparison of severity of hypocalcemia in both arm | The severity of hypocalcemia will be measured in both arm, to see if a significant difference is observed, with items listed below : Calcemia, corrected for albuminemia, of less than 1.90 mmol / L the use of calcium gluconate IV in the first 15 post-operative days) duration of hypocalcemia's symptoms in the first 15 days postoperative | At Day 1, Day 2 and Day 15 | 
| Comparison of the effect of supplementation on vitamin D deficiency in both arm | Comparison between measured initial value of 25OHD at the inclusion visit to the measured value of 25OHD on the day of the operation in both groups. | At Day 0 | 
| Comparison of parathyroid activity in both arm | Parathyroid activity will be evaluated in both group by measuring parathormone (PTH). Hypoparathyroidism being defined by PTH < 15 ng / L. | At Day 0 (= Surgery), at Hour 4 post-surgery, Day 2 and Day 15 | 
| Assessment of the prevalence of definitive hypocalcemia | Collect of the definitive hypocalcemia's numbers in each group | At Day 15 | 
| Assessment of the effect of vitamin D supplementation on the occurrence of hypocalcemia in risk groups: hyperthyroidism, cancer, dissection associated with thyroidectomy | Collect of the number of adverse events and serum calcium levels for each participant | At Day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total thyroidectomy, hypocalcemia, cholecalciferol supplementation