Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation

NCT04775381 | Recruiting Phase 3 DMC

• 2 other identifiers: CHRD 21152018-000526-64
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Hypocalcemia

Keywords

Total thyroidectomy; hypocalcemia; cholecalciferol supplementation

Outcome Measures

Primary Outcomes (1)

• Assessment of the effect of pre-operative cholecalciferol supplementation on the occurrence of post-operative hypocalcemia after total thyroidectomy

  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

  At Day 15 after surgery

Secondary Outcomes (6)

• Comparison of clinical course in both Arm

  At 3 month

• Comparison of severity of hypocalcemia in both arm

  At Day 1, Day 2 and Day 15

• Comparison of the effect of supplementation on vitamin D deficiency in both arm

  At Day 0

• Comparison of parathyroid activity in both arm

  At Day 0 (= Surgery), at Hour 4 post-surgery, Day 2 and Day 15

• Assessment of the prevalence of definitive hypocalcemia

  At Day 15

Study Arms (2)

Vitamin D

EXPERIMENTAL

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

Drug: Vitamin D

Fruit juice

NO INTERVENTION

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

Interventions

Vitamin D DRUG

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

Also known as: Treatment

Vitamin D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• OHD 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

Sponsors & Collaborators

• Hôpital NOVO: lead

Study Sites (6)

Department of General, Digestive and Endocrine Surgery

Auxerre, 89000, France

TERMINATED

Department of ENT and maxillofacial surgery

Corbeil-Essonnes, 91100, France

RECRUITING

Department of Head and Neck Surgery and ENT

La Roche-sur-Yon, 85000, France

RECRUITING

Hospital Lariboisière, Paris X

Paris, 75010, France

TERMINATED

Hospital Poissy/Saint-Germain

Poissy, 78300, France

RECRUITING

Hospital René Dubos,

Pontoise, 95300, France

RECRUITING

MeSH Terms

Conditions

Hypocalcemia

Interventions

Vitamin D; Therapeutics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Dr Khaled AL TABAA

  Hôpital NOVO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maryline Delattre

CONTACT

+33 1 30 75 41 31; maryline.delattre@ght-novo.fr

Veronique Da Costa

CONTACT

+33 1 30 75 50 69; veronique.dacosta@ght-novo.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: March 1, 2021
• Study Start: June 30, 2021
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

FR (6)