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

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ClinicalTrials.gov Identifier: NCT04775381
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : May 16, 2023
Sponsor:
Information provided by (Responsible Party):
Hôpital NOVO

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

Condition or disease Intervention/treatment Phase
Hypocalcemia Drug: Vitamin D Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Study of Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation
Actual Study Start Date : June 30, 2021
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arms and Interventions
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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 Name: Treatment
No Intervention: Fruit juice
During preoperative visit (Month -2) patients will receive only fruit juice.


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of the effect of pre-operative cholecalciferol supplementation on the occurrence of post-operative hypocalcemia after total thyroidectomy [ Time Frame: At Day 15 after surgery ]

    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 :
  1. Comparison of clinical course in both Arm [ Time Frame: At 3 month ]

    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)

  2. Comparison of severity of hypocalcemia in both arm [ Time Frame: At Day 1, Day 2 and Day 15 ]

    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

  3. Comparison of the effect of supplementation on vitamin D deficiency in both arm [ Time Frame: At Day 0 ]
    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.

  4. Comparison of parathyroid activity in both arm [ Time Frame: At Day 0 (= Surgery), at Hour 4 post-surgery, Day 2 and Day 15 ]

    Parathyroid activity will be evaluated in both group by measuring parathormone (PTH).

    Hypoparathyroidism being defined by PTH < 15 ng / L.


  5. Assessment of the prevalence of definitive hypocalcemia [ Time Frame: At Day 15 ]
    Collect of the definitive hypocalcemia's numbers in each group

  6. Assessment of the effect of vitamin D supplementation on the occurrence of hypocalcemia in risk groups: hyperthyroidism, cancer, dissection associated with thyroidectomy [ Time Frame: At Day 15 ]
    Collect of the number of adverse events and serum calcium levels for each participant


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04775381


Contacts
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Contact: Maryline Delattre 0033130754131 maryline.delattre@ght-novo.fr
Contact: Veronique Da Costa 0033130755069 veronique.dacosta@ght-novo.fr

Locations
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France
Department of General, Digestive and Endocrine Surgery Recruiting
Auxerre, France, 89000
Contact: Dr Baptiste BORRACCINO    +33 3 86 48 44 35    bborraccino@ch-auxerre.fr   
Department of ENT and maxillofacial surgery Recruiting
Corbeil-Essonnes, France, 91100
Contact: Dr Tam CLOUTIER    +33 1 61 69 72 22    tamcloutier@gmail.com   
Department of Head and Neck Surgery and ENT Recruiting
La Roche-sur-Yon, France, 85000
Contact: Dr Kevin BUQUET    +33 2 51 44 65 72    kevin.buquet@ght85.fr   
Hospital Lariboisière, Paris X Recruiting
Paris, France, 75010
Contact: Pr Romain KANIA    +331 49 95 80 57    romain.kania@aphp.fr   
Hospital Poissy/Saint-Germain Recruiting
Poissy, France, 78300
Contact: Pr Didier SIMON    01 39 27 42 69    didier.simon@ght-yvelinesnord.fr   
Hospital René Dubos, Recruiting
Pontoise, France, 95300
Contact: Dr Khaled AL TABAA    01 30 75 71 51    khaled.altabaa@ght-novo.fr   
Sponsors and Collaborators
Hôpital NOVO
Investigators
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Principal Investigator: Dr Khaled AL TABAA Hôpital NOVO
More Information
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Responsible Party: Hôpital NOVO
ClinicalTrials.gov Identifier: NCT04775381    
Other Study ID Numbers: CHRD 2115
2018-000526-64 ( EudraCT Number )
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: May 16, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hôpital NOVO:
Total thyroidectomy
hypocalcemia
cholecalciferol supplementation
Additional relevant MeSH terms:
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Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Vitamin D
 Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents