Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation (CAVITHY)
Primary Purpose
Hypocalcemia
Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
About this trial
This is an interventional prevention trial for Hypocalcemia focused on measuring Total thyroidectomy, hypocalcemia, cholecalciferol supplementation
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)
Sites / Locations
- Department of General, Digestive and Endocrine SurgeryRecruiting
- Department of ENT and maxillofacial surgeryRecruiting
- Department of Head and Neck Surgery and ENTRecruiting
- Hospital Lariboisière, Paris XRecruiting
- Hospital Poissy/Saint-GermainRecruiting
- Hospital René Dubos,Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Vitamin D
Fruit juice
Arm Description
During preoperative visit (Month -2) patients will receive a cholecalciferol supplementation added to a fruit juice.
During preoperative visit (Month -2) patients will receive only fruit juice.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
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
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.
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.
Assessment of the prevalence of definitive hypocalcemia
Collect of the definitive hypocalcemia's numbers in each group
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04775381
Brief Title
Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation
Acronym
CAVITHY
Official Title
Study of Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital NOVO
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypocalcemia
Keywords
Total thyroidectomy, hypocalcemia, cholecalciferol supplementation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
During preoperative visit (Month -2) patients will receive a cholecalciferol supplementation added to a fruit juice.
Arm Title
Fruit juice
Arm Type
No Intervention
Arm Description
During preoperative visit (Month -2) patients will receive only fruit juice.
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
Treatment
Intervention Description
Patients will receive a cholecalciferol supplementation added to a fruit juice.
Primary Outcome Measure Information:
Title
Assessment of the effect of pre-operative cholecalciferol supplementation on the occurrence of post-operative hypocalcemia after total thyroidectomy
Description
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
Time Frame
At Day 15 after surgery
Secondary Outcome Measure Information:
Title
Comparison of clinical course in both Arm
Description
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)
Time Frame
At 3 month
Title
Comparison of severity of hypocalcemia in both arm
Description
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
Time Frame
At Day 1, Day 2 and Day 15
Title
Comparison of the effect of supplementation on vitamin D deficiency in both arm
Description
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.
Time Frame
At Day 0
Title
Comparison of parathyroid activity in both arm
Description
Parathyroid activity will be evaluated in both group by measuring parathormone (PTH).
Hypoparathyroidism being defined by PTH < 15 ng / L.
Time Frame
At Day 0 (= Surgery), at Hour 4 post-surgery, Day 2 and Day 15
Title
Assessment of the prevalence of definitive hypocalcemia
Description
Collect of the definitive hypocalcemia's numbers in each group
Time Frame
At Day 15
Title
Assessment of the effect of vitamin D supplementation on the occurrence of hypocalcemia in risk groups: hyperthyroidism, cancer, dissection associated with thyroidectomy
Description
Collect of the number of adverse events and serum calcium levels for each participant
Time Frame
At Day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maryline Delattre
Phone
0033130754131
Email
maryline.delattre@ght-novo.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Veronique Da Costa
Phone
0033130755069
Email
veronique.dacosta@ght-novo.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Khaled AL TABAA
Organizational Affiliation
Hôpital NOVO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of General, Digestive and Endocrine Surgery
City
Auxerre
ZIP/Postal Code
89000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Baptiste BORRACCINO
Phone
+33 3 86 48 44 35
Email
bborraccino@ch-auxerre.fr
Facility Name
Department of ENT and maxillofacial surgery
City
Corbeil-Essonnes
ZIP/Postal Code
91100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Tam CLOUTIER
Phone
+33 1 61 69 72 22
Email
tamcloutier@gmail.com
Facility Name
Department of Head and Neck Surgery and ENT
City
La Roche-sur-Yon
ZIP/Postal Code
85000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Kevin BUQUET
Phone
+33 2 51 44 65 72
Email
kevin.buquet@ght85.fr
Facility Name
Hospital Lariboisière, Paris X
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pr Romain KANIA
Phone
+331 49 95 80 57
Email
romain.kania@aphp.fr
Facility Name
Hospital Poissy/Saint-Germain
City
Poissy
ZIP/Postal Code
78300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pr Didier SIMON
Phone
01 39 27 42 69
Email
didier.simon@ght-yvelinesnord.fr
Facility Name
Hospital René Dubos,
City
Pontoise
ZIP/Postal Code
95300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Khaled AL TABAA
Phone
01 30 75 71 51
Email
khaled.altabaa@ght-novo.fr
12. IPD Sharing Statement
Learn more about this trial
Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation
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