Actively Recruiting
Study of Post-thyroidectomy Hypocalcemia After Preoperative Vitamin D3 (Cholecalciferol) Supplementation
Led by Hôpital NOVO · Updated on 2025-01-20
200
Participants Needed
6
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how taking vitamin D3 before surgery might affect the chance of low calcium levels after total thyroidectomy, a common surgery to remove the thyroid gland. This study focuses on patients undergoing this surgery for any reason and investigates whether preoperative vitamin D deficiency plays a role in post-surgery hypocalcemia, especially in thyroid cancer patients. The study is a prospective Phase 3 trial aiming to better understand this potential connection. Participants will receive vitamin D3 (cholecalciferol) supplementation mixed with fruit juice before their total thyroidectomy. The study monitors the effects of this preoperative vitamin D administration on the occurrence of low calcium levels after surgery. The treatment is given prior to surgery, and patients are followed to assess calcium levels postoperatively. During the study, participants will be assessed for calcium levels 15 days after surgery to determine if preoperative vitamin D supplementation affects the risk of hypocalcemia. Researchers will collect data on safety and any complications related to calcium imbalance. The total participation includes screening, supplementation before surgery, surgery itself, and postoperative follow-up to monitor calcium status and overall safety.
CONDITIONS
Official 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
- Scheduled for a total thyroidectomy surgery for any reason
- Provided written informed consent to participate
- Affiliated with the social security system
You will not qualify if you...
- History of thyroid or parathyroid surgery, hyperparathyroidism, or granulomatosis flare-up
- Existing hypocalcemia, hypercalcemia, or related symptoms not due to thyroid issues
- Chronic kidney disease grade 4 or higher
- Severe liver failure
- Vitamin D supplementation in the 3 months before surgery
- Malabsorption syndrome
- Known allergy to vitamin D
- History of calcium kidney stones
- Pregnancy
- Under guardianship or trusteeship (vulnerable populations)
- Allergy to any component of the fruit juice used in supplementation
AI-Screening
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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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