HypocalcemiaPhase 3CAVITHYNCT04775381
Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation
A Phase 3 study testing Vitamin D in people with Hypocalcemia, run by Hôpital NOVO at 6 sites in France.
Trial summary
This prospective study evalue the inflence of pre operative vit D3 administration on post operative hypocalcemia in patients undergoing Total thyroidectomy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypocalcemia
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 6 sitesFrance
- Study dates
- 30 Jun 2021to Mar 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 4 recruiting
- Terminated
Department of General, Digestive and Endocrine Surgery
Auxerre, 89000
- Recruiting
Department of ENT and maxillofacial surgery
Corbeil-Essonnes, 91100
Dr Tam CLOUTIER, +33 1 61 69 72 22, tamcloutier@gmail.com
- Recruiting
Department of Head and Neck Surgery and ENT
La Roche-sur-Yon, 85000
Dr Kevin BUQUET, +33 2 51 44 65 72, kevin.buquet@ght85.fr
- Terminated
Hospital Lariboisière, Paris X
Paris, 75010
- Recruiting
Hospital Poissy/Saint-Germain
Poissy, 78300
Pr Didier SIMON, ++33 1 39 27 42 69, didier.simon@ght-yvelinesnord.fr
- Recruiting
Hospital René Dubos,
Pontoise, 95300
Dr Khaled AL TABAA, +33 1 30 75 71 51, khaled.altabaa@ght-novo.fr
About this study
Official title: Study of Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation
This prospective study evalue the inflence of pre operative vit D3 administration on post operative hypocalcemia in patients undergoing Total thyroidectomy
Read the detailed 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.
- Conditions
- Hypocalcemia
- Being tested
- Vitamin D
- Keywords
- Total thyroidectomy, hypocalcemia, cholecalciferol supplementation
- Medical subject headings
- Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called Treatment
Patients will receive a cholecalciferol supplementation added to a fruit juice.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | During preoperative visit (Month -2) patients will receive a cholecalciferol supplementation added to a fruit juice. Receives: Drug: Vitamin D |
| Fruit juice | No intervention | During preoperative visit (Month -2) patients will receive only fruit juice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At Day 15 after surgery
Secondary outcomes (6)
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)
Measured: At 3 month
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
Measured: At Day 1, Day 2 and Day 15
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.
Measured: At Day 0
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.
Measured: At Day 0 (= Surgery), at Hour 4 post-surgery, Day 2 and Day 15
Assessment of the prevalence of definitive hypocalcemia
Collect of the definitive hypocalcemia's numbers in each group
Measured: At Day 15
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
Measured: At Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start30 Jun 2021
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypocalcemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Khaled AL TABAA, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775381
- Sponsor's protocol ID
- CHRD 2115
- Other IDs
- 2018-000526-64, 2018
- Acronym
- CAVITHY
- Status last verified
- Jan 2025
- First submitted
- 19 Feb 2021
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation
- ClinicalTrials.gov ID
- NCT04775381
- Acronym / sponsor ID
- CAVITHY / CHRD 2115
- Conditions
- Hypocalcemia
- Keywords
- Total thyroidectomy, hypocalcemia, cholecalciferol supplementation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective study evalue the inflence of pre operative vit D3 administration on post operative hypocalcemia in patients undergoing Total thyroidectomy
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Drug: Vitamin DDuring preoperative visit (Month -2) patients will receive a cholecalciferol supplementation added to a fruit juice. |
| Fruit juice | No intervention | –During preoperative visit (Month -2) patients will receive only fruit juice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: TreatmentPatients will receive a cholecalciferol supplementation added to a fruit juice. | Drug | Vitamin D |
Primary outcome
Assessment of the effect of pre-operative cholecalciferol supplementation on the occurrence of post-operative hypocalcemia after total thyroidectomy
Time frame: At Day 15 after surgery
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
6 secondary outcomes
Comparison of clinical course in both Arm
Time frame: At 3 month
Comparison of severity of hypocalcemia in both arm
Time frame: At Day 1, Day 2 and Day 15
Comparison of the effect of supplementation on vitamin D deficiency in both arm
Time frame: At Day 0
Comparison of parathyroid activity in both arm
Time frame: At Day 0 (= Surgery), at Hour 4 post-surgery, Day 2 and Day 15
Assessment of the prevalence of definitive hypocalcemia
Time frame: At Day 15
Assessment of the effect of vitamin D supplementation on the occurrence of hypocalcemia in risk groups: hyperthyroidism, cancer, dissection associated with thyroidectomy
Time frame: At Day 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Khaled AL TABAA principal investigator
Hôpital NOVO
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D in people with Hypocalcemia, run by Hôpital NOVO at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maryline Delattre (+33 1 30 75 41 31, maryline.delattre@ght-novo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the effect of pre-operative cholecalciferol supplementation on the occurrence of post-operative hypocalcemia after total thyroidectomy (time frame: At Day 15 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.