Actively Recruiting
Study of Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation
Led by Hôpital NOVO · Updated on 2025-01-20
200
Participants Needed
6
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of giving vitamin D3 before surgery on low calcium levels after total thyroidectomy. This prospective study focuses on patients undergoing total thyroid removal, a common surgery that can lead to temporary low calcium in the blood. The study aims to clarify if vitamin D deficiency before surgery increases the risk of low calcium after thyroidectomy, especially in cases involving thyroid cancer and central neck dissection. Participants are randomly assigned to one of two groups. One group receives vitamin D3 (cholecalciferol) added to fruit juice during a preoperative visit about two months before surgery. The other group receives only fruit juice without vitamin D. The study is double-blinded, meaning neither patients nor researchers know who receives vitamin D or placebo. During the study, patients are monitored for calcium levels and parathyroid activity at various times: before surgery, shortly after surgery, and up to 15 days post-surgery, with additional follow-up at three months. The main outcome measured is the occurrence of low calcium 15 days after surgery. Researchers also compare the severity of low calcium, vitamin D levels, and effects in different risk groups. The total participation period includes preoperative supplementation and postoperative follow-up until three months after surgery.
CONDITIONS
Brief Title
Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient 18 years old or older
- Patient scheduled for total thyroidectomy surgery
- Written informed consent obtained
- Patients affiliated with the social security system
You will not qualify if you...
- History of thyroid or parathyroid surgery
- History of hyperparathyroidism or granulomatosis flare-up
- Hypocalcemia or hypercalcemia symptoms unrelated to thyroid issues
- Chronic kidney disease grade 4 or higher
- Severe liver failure
- Vitamin D supplementation within 3 months before surgery
- Malabsorption syndrome
- Known allergy to vitamin D
- History of calcium kidney stones
- Pregnancy
- Vulnerable populations under guardianship or trusteeship
- Allergies to components of the fruit juice
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 2 months before surgery
Participants receive preoperative cholecalciferol supplementation or fruit juice during a preoperative visit approximately 2 months before surgery.
1 preoperative visit (in-person)
Duration - 15 days after surgery
Participants undergo total thyroidectomy surgery and are monitored for hypocalcemia and parathyroid activity immediately after surgery and up to 15 days post-operation.
Visits at surgery day, hour 4 post-surgery, day 1, day 2, and day 15 (in-person)
Duration - 3 months after surgery
Participants are followed to compare clinical course and hypocalcemia severity up to 3 months after surgery.
Follow-up visits up to 3 months
Trial Site Locations
Total: 6 locations
1
Department of General, Digestive and Endocrine Surgery
Auxerre, France, 89000
Terminated
2
Department of ENT and maxillofacial surgery
Corbeil-Essonnes, France, 91100
Actively Recruiting
3
Department of Head and Neck Surgery and ENT
La Roche-sur-Yon, France, 85000
Actively Recruiting
4
Hospital Lariboisière, Paris X
Paris, France, 75010
Terminated
5
Hospital Poissy/Saint-Germain
Poissy, France, 78300
Actively Recruiting
6
Hospital René Dubos,
Pontoise, France, 95300
Actively Recruiting
Research Team
M
Maryline Delattre
V
Veronique Da Costa
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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