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

Hôpital NOVO

Status and phase: Enrolling; Phase 3

Conditions: Hypocalcemia

Treatments: Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT04775381

2018-000526-64 (EudraCT Number)

CHRD 2115

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Vitamin D

Experimental group

Description:

During preoperative visit (Month -2) patients will receive a cholecalciferol supplementation added to a fruit juice.

Treatment:

Drug: Vitamin D

Fruit juice

No Intervention group

Description:

During preoperative visit (Month -2) patients will receive only fruit juice.