Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation
NCT ID: NCT04775381
Last Updated: 2025-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2021-06-30
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Vitamin D
During preoperative visit (Month -2) patients will receive a cholecalciferol supplementation added to a fruit juice.
Vitamin D
Patients will receive a cholecalciferol supplementation added to a fruit juice.
Fruit juice
During preoperative visit (Month -2) patients will receive only fruit juice.
No interventions assigned to this group
Interventions
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Vitamin D
Patients will receive a cholecalciferol supplementation added to a fruit juice.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hôpital NOVO
OTHER
Responsible Party
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Principal Investigators
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Dr Khaled AL TABAA
Role: PRINCIPAL_INVESTIGATOR
Hôpital NOVO
Locations
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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, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHRD 2115
Identifier Type: -
Identifier Source: org_study_id
2018-000526-64
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
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