Study of total post-thyroidectomy hypocalcemia after preoperative cholecalciferol supplementation

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hopital NOVO

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Not possible to specify

Trial duration

16 Oct 2024 → 30 Jan 2026

Decision date (initial)

2024-10-16

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-516793-30-00

EudraCT number

2018-000526-64

ClinicalTrials.gov

NCT04775381

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

Assessment of the effect of pre-operative cholecalciferol supplementation on the occurrence of post-operative hypocalcemia aftertotal thyroidectomy

Secondary objectives 6

1. Group Treatment vs group no treatment: Assessment of length of hospital stay and readmissions during follow-up
2. Group Treatment vs group no treatment: Assessment of severity of hypocalcemia
3. Group Treatment vs group no treatment: Assessment of the effect of supplementation on vitamin D deficiency
4. Group Treatment vs group no treatment: Assessment of parathyroid activity
5. Assessment of the prevalence of definitive hypocalcemia
6. Assessment of the effect of vitamin D supplementation on the occurrence of hypocalcemia in risk groups: hyperthyroidism, cancer, dissection associated with thyroidectomy

Conditions and MedDRA coding

Thyroidectomy is a common operation. Transient postoperative hypocalcemia is the main complication, resulting in clinical discomfort for patients, longer hospital stays and increased perioperative cost. Cholecalciferol is used to supplement vitamin D deficiency. We suppose that systematic pre-operative supplementation with cholecalciferol would allow a faster and more appropriate response to post-operative hypocalcemia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patient ≥ 18 years old
2. Patient shall be operated on for a total thyroidectomy in one time for any indication
3. Written informed consent (IC) obtained
4. Patients with affiliation to the social security system

Exclusion criteria 12

1. Medical history of : thyroid or parathyroid surgery, Hyperparathyroidism , granulomatosis flare-up
2. Chronic kidney disease grade ≥4
3. 25OHD supplementation within last 3 months before surgery
4. Malabsorption syndrome
5. Known hypersensitivity to vitamin D
6. Allergies to one of the components of the fruit juice
7. Medical history of calcic lithiasis
8. Hypocalcemia, hypercalcemia/ hypercalciuria, or symptom of Hypocalcemia, hypercalcemia/ hypercalciuria, not due to thyroid pathologies
9. Severe liver failure
10. Pregnant women
11. Vulnerable populations (guardianship or trusteeship)
12. Persons deprived of their liberty by court or administrative decision

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 D15

Secondary endpoints 7

1. Duration of initial hospitalization (number of hospital days), collect of adverse events and number of readmissions
2. Measure of severity of hypocalcemia defined by a calcemia corrected for albuminemia of less than 1.90 mmol / L and / or the use of calcium gluconate IV in the first 15 post-operative days.
3. Measure of duration of hypocalcemia's symptoms in the first 15 days postoperative
4. Vitamin D deficiency will be measured by comparing the initial value of 25OHD at the inclusion visit to the value of 25OHD of the day of the operation (D0=H0)
5. Collect of the number of adverse events and serum calcium levels for each participant
6. Collect of the definitive hypocalcemia's numbers in each group
7. Parathyroid activity will be evaluated in both group by measuring parathormone (PTH). Hypoparathyroidism being defined by PTH < 15 ng / L.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hopital NOVO

Sponsor organisation

Hopital NOVO

Address

6 Avenue De L Ile De France

City

Pontoise

Postcode

95300

Country

France

Scientific contact point

Organisation

Hopital NOVO

Contact name

AL TABAA Khaled

Public contact point

Organisation

Hopital NOVO

Contact name

DELATTRE Maryline

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications