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NCT Number: NCT04775381

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

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Key information

Conditions

Hypocalcemia Calcium Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of General, Digestive and Endocrine Surgery, Auxerre, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Drug

Patients will receive a cholecalciferol supplementation added to a fruit juice.

Other names: Treatment

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Maryline Delattre

CONTACT

[email protected]

+33 1 30 75 41 31

Veronique Da Costa

CONTACT

[email protected]

+33 1 30 75 50 69

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Registry information

Official study title

Study of Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation

Acronym: CAVITHY

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Mar 1, 2021
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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