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Recruiting NCT04775381

Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation

Phase III Interventional Hypocalcemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vitamin D.
Who it may be relevant to
Registry conditions: Hypocalcemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Study of Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation

Overview

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.

Interventions

  • Drug Vitamin D
    Patients will receive a cholecalciferol supplementation added to a fruit juice.

Primary outcome measures

  • 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]
Secondary outcome measures (6)
  • Comparison of clinical course in both Arm [Time frame: At 3 month]
  • Comparison of severity of hypocalcemia in both arm [Time frame: At Day 1, Day 2 and Day 15]
  • Comparison of the effect of supplementation on vitamin D deficiency in both arm [Time frame: At Day 0]
  • Comparison of parathyroid activity in both arm [Time frame: At Day 0 (= Surgery), at Hour 4 post-surgery, Day 2 and Day 15]
  • Assessment of the prevalence of definitive hypocalcemia [Time frame: 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 [Time frame: At Day 15]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

France · 6 centers
  • Department of General, Digestive and Endocrine Surgery — Auxerre
  • Department of ENT and maxillofacial surgery — Corbeil-Essonnes
  • Department of Head and Neck Surgery and ENT — La Roche-sur-Yon
  • Hospital Lariboisière, Paris X — Paris
  • Hospital Poissy/Saint-Germain — Poissy
  • Hospital René Dubos, — Pontoise

Identifiers

NCT: NCT04775381 · CHRD 2115 · 2018-000526-64

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗