Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation

NCT ID: NCT04775381

Last Updated: 2025-01-20

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2026-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypocalcemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vitamin D

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

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

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

Fruit juice

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vitamin D

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

Intervention Type DRUG

Other Intervention Names

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Treatment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital NOVO

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status TERMINATED

Department of ENT and maxillofacial surgery

Corbeil-Essonnes, , France

Site Status RECRUITING

Department of Head and Neck Surgery and ENT

La Roche-sur-Yon, , France

Site Status RECRUITING

Hospital Lariboisière, Paris X

Paris, , France

Site Status TERMINATED

Hospital Poissy/Saint-Germain

Poissy, , France

Site Status RECRUITING

Hospital René Dubos,

Pontoise, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Maryline Delattre

Role: CONTACT

+33 1 30 75 41 31

Veronique Da Costa

Role: CONTACT

+33 1 30 75 50 69

Facility Contacts

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Dr Tam CLOUTIER

Role: primary

+33 1 61 69 72 22

Dr Kevin BUQUET

Role: primary

+33 2 51 44 65 72

Pr Didier SIMON

Role: primary

++33 1 39 27 42 69

Dr Khaled AL TABAA

Role: primary

+33 1 30 75 71 51

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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