Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation (CAVITHY)

Study of Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation

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

Study Overview

• Status: Recruiting
• Conditions: Hypocalcemia
• Intervention / Treatment: Drug: Vitamin D

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Veronique Da Costa; Phone Number: +33 1 30 75 50 69; Email: veronique.dacosta@ght-novo.fr
• Study Contact Backup: Name: Maryline Delattre; Phone Number: +33 1 30 75 41 31; Email: maryline.delattre@ght-novo.fr

Study Locations

• France
  • Auxerre, France, 89000
    • Terminated
    • Department of General, Digestive and Endocrine Surgery
  • Corbeil-Essonnes, France, 91100
    • Recruiting
    • Department of ENT and maxillofacial surgery
    • Contact: Dr Tam CLOUTIER; Phone Number: +33 1 61 69 72 22; Email: tamcloutier@gmail.com
  • La Roche-sur-Yon, France, 85000
    • Recruiting
    • Department of Head and Neck Surgery and ENT
    • Contact: Dr Kevin BUQUET; Phone Number: +33 2 51 44 65 72; Email: kevin.buquet@ght85.fr
  • Paris, France, 75010
    • Terminated
    • Hospital Lariboisière, Paris X
  • Poissy, France, 78300
    • Recruiting
    • Hospital Poissy/Saint-Germain
    • Contact: Pr Didier SIMON; Phone Number: ++33 1 39 27 42 69; Email: didier.simon@ght-yvelinesnord.fr
  • Pontoise, France, 95300
    • Recruiting
    • Hospital René Dubos,
    • Contact: Dr Khaled AL TABAA; Phone Number: +33 1 30 75 71 51; Email: khaled.altabaa@ght-novo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hôpital NOVO
• Investigators: Principal Investigator: Dr Khaled AL TABAA, Hôpital NOVO

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: February 19, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: hypocalcemia; Total thyroidectomy; cholecalciferol supplementation
• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Calcium Metabolism Disorders; Hypocalcemia; Physiological Effects of Drugs; Bone Density Conservation Agents; Micronutrients; Vitamins; Vitamin D
• Other Study ID Numbers: CHRD 2115; 2018-000526-64 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No