Clinical trial NCT04775381: Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation
Official title: Study of Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hypocalcemia
Keywords: Total thyroidectomy
hypocalcemia
cholecalciferol supplementation
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of the effect of pre-operative cholecalciferol supplementation on the occurrence of post-operative hypocalcemia after total thyroidectomy
timeFrame: At Day 15 after surgery
Secondary outcomes:
measure: Comparison of clinical course in both Arm
timeFrame: At 3 month
measure: Comparison of severity of hypocalcemia in both arm
timeFrame: At Day 1, Day 2 and Day 15
measure: Comparison of the effect of supplementation on vitamin D deficiency in both arm
timeFrame: At Day 0
measure: Comparison of parathyroid activity in both arm
timeFrame: At Day 0 (= Surgery), at Hour 4 post-surgery, Day 2 and Day 15
measure: Assessment of the prevalence of definitive hypocalcemia
timeFrame: At Day 15
measure: Assessment of the effect of vitamin D supplementation on the occurrence of hypocalcemia in risk groups: hyperthyroidism, cancer, dissection associated with thyroidectomy
timeFrame: At Day 15
Other outcomes:
Locations:
city: Auxerre
country: France
facility: Department of General, Digestive and Endocrine Surgery
city: Corbeil-Essonnes
country: France
facility: Department of ENT and maxillofacial surgery
city: La Roche-sur-Yon
country: France
facility: Department of Head and Neck Surgery and ENT
city: Paris
country: France
facility: Hospital Lariboisière, Paris X
city: Poissy
country: France
facility: Hospital Poissy/Saint-Germain
city: Pontoise
country: France
facility: Hospital René Dubos,
Study officials:
affiliation: Hôpital NOVO
name: Dr Khaled AL TABAA
role: PRINCIPAL_INVESTIGATOR
References: