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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04775381
Other study ID # CHRD 2115
Secondary ID 2018-000526-64
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 30, 2021
Est. completion date June 2025

Study information

Verified date June 2024
Source Hôpital NOVO
Contact Maryline Delattre
Phone 0033130754131
Email maryline.delattre@ght-novo.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date June 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Department of General, Digestive and Endocrine Surgery Auxerre
France Department of ENT and maxillofacial surgery Corbeil-Essonnes
France Department of Head and Neck Surgery and ENT La Roche-sur-Yon
France Hospital Lariboisière, Paris X Paris
France Hospital Poissy/Saint-Germain Poissy
France Hospital René Dubos, Pontoise

Sponsors (1)

Lead Sponsor Collaborator
Hôpital NOVO

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Comparison of clinical course in both Arm Clinical course will be measured, for several items, and compared between both groups to see if a significant difference is observed.
Items, considered for comparison, are listed below :
Initial hospital stay (number of days),
number of readmission,
adverse event (number)
At 3 month
Secondary Comparison of severity of hypocalcemia in both arm The severity of hypocalcemia will be measured in both arm, to see if a significant difference is observed, with items listed below :
Calcemia, corrected for albuminemia, of less than 1.90 mmol / L
the use of calcium gluconate IV in the first 15 post-operative days)
duration of hypocalcemia's symptoms in the first 15 days postoperative
At Day 1, Day 2 and Day 15
Secondary Comparison of the effect of supplementation on vitamin D deficiency in both arm Comparison between measured initial value of 25OHD at the inclusion visit to the measured value of 25OHD on the day of the operation in both groups. At Day 0
Secondary Comparison of parathyroid activity in both arm Parathyroid activity will be evaluated in both group by measuring parathormone (PTH).
Hypoparathyroidism being defined by PTH < 15 ng / L.
At Day 0 (= Surgery), at Hour 4 post-surgery, Day 2 and Day 15
Secondary Assessment of the prevalence of definitive hypocalcemia Collect of the definitive hypocalcemia's numbers in each group At Day 15
Secondary Assessment of the effect of vitamin D supplementation on the occurrence of hypocalcemia in risk groups: hyperthyroidism, cancer, dissection associated with thyroidectomy Collect of the number of adverse events and serum calcium levels for each participant At Day 15
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