CAVITHY: Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation

Sponsor
Centre Hospitalier René Dubos (Other)
Overall Status
Recruiting
CT.gov ID
NCT04775381
Collaborator
(none)
200
3
2
44
66.7
1.5

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • 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

Study Type:
Interventional
Anticipated 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 :
Jun 30, 2021
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of the effect of pre-operative cholecalciferol supplementation on the occurrence of post-operative hypocalcemia after total thyroidectomy [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 [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 [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 [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 [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 [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 [At Day 15]

      Collect of the number of adverse events and serum calcium levels for each participant

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Lariboisière, Paris X Paris France 75010
    2 Hospital Poissy/Saint-Germain Poissy France 78300
    3 Hospital René Dubos, Pontoise France 95300

    Sponsors and Collaborators

    • Centre Hospitalier René Dubos

    Investigators

    • Principal Investigator: Dr Khaled AL TABAA, Centre Hospitalier René Dubos

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier René Dubos
    ClinicalTrials.gov Identifier:
    NCT04775381
    Other Study ID Numbers:
    • CHRD 2115
    • 2018-000526-64
    First Posted:
    Mar 1, 2021
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier René Dubos
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 22, 2022