NCT04775381 Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation
| NCT ID | NCT04775381 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Hôpital NOVO |
| Condition | Hypocalcemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-06-30 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 200 participants in total. It began in 2021-06-30 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This prospective study evalue the inflence of pre operative vit D3 administration on post operative hypocalcemia in patients undergoing Total thyroidectomy
Eligibility Criteria
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
Contact & Investigator
Dr Khaled AL TABAA
PRINCIPAL INVESTIGATOR
Hôpital NOVO
Frequently Asked Questions
Who can join the NCT04775381 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypocalcemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04775381 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 200 participants.
Is NCT04775381 currently recruiting?
Yes, NCT04775381 is actively recruiting participants. Contact the research team at maryline.delattre@ght-novo.fr for enrollment information.
Where is the NCT04775381 trial being conducted?
This trial is being conducted at Auxerre, France, Corbeil-Essonnes, France, La Roche-sur-Yon, France, Paris, France and 2 additional locations.
Who is sponsoring the NCT04775381 clinical trial?
NCT04775381 is sponsored by Hôpital NOVO. The principal investigator is Dr Khaled AL TABAA at Hôpital NOVO. The trial plans to enroll 200 participants.