Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation

Hypocalcemia Clinical Trial

— CAVITHY  

Official title:

Study of Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04775381
• Other study ID #: CHRD 2115
• Secondary ID: 2018-000526-64
• Status: Recruiting
• Phase: Phase 3
• Start date: June 30, 2021
• Est. completion date: June 2025

Study information

• Verified date: May 2023
• Source: Centre Hospitalier René Dubos
• Contact: Maryline Delattre
• Phone: 0033130754131
• Email: maryline.delattre[@]ght-novo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypocalcemia

Intervention

Drug:
• Vitamin D
Patients will receive a cholecalciferol supplementation added to a fruit juice.

Locations

Country	Name	City	State
France	Department of General, Digestive and Endocrine Surgery	Auxerre
France	Department of ENT and maxillofacial surgery	Corbeil-Essonnes
France	Department of Head and Neck Surgery and ENT	La Roche-sur-Yon
France	Hospital Lariboisière, Paris X	Paris
France	Hospital Poissy/Saint-Germain	Poissy
France	Hospital René Dubos,	Pontoise

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier René Dubos

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Assessment of the prevalence of definitive hypocalcemia	Collect of the definitive hypocalcemia's numbers in each group	At Day 15
Secondary	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