Effect of Vitamin D on Post-Thyroidectomy Hypocalcemia
Official title: Study of Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation
Run by Hôpital NOVO · NCT04775381 · Data updated 2026-11-12
This study is testing whether taking vitamin D before thyroid surgery can help prevent low calcium levels after the operation in patients with thyroid issues.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Hôpital NOVO Academic / other |
| Locations | 6 sites (Auxerre and 5 other locations) |
| Status | Recruiting |
| Started | June 30, 2021 |
| Main results expected | December 2025 |
| Study ends | March 2026 |
| Registry record updated | January 20, 2025 |
| Trial ID | NCT04775381 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who are scheduled for a total thyroidectomy for any indication.
✕Probably not a fit
Patients with a history of thyroid or parathyroid surgery, severe liver failure, or chronic kidney disease grade ≥4 may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective study evaluates the impact of preoperative vitamin D3 supplementation on the occurrence of postoperative hypocalcemia in patients undergoing total thyroidectomy. The research focuses on patients with non-toxic multinodular goiter or Graves' disease, as well as those with thyroid cancer undergoing additional neck dissection. By assessing vitamin D levels and their correlation with hypocalcemia post-surgery, the study aims to clarify the role of vitamin D deficiency as a risk factor in these patients. The findings could provide insights into improving postoperative outcomes through nutritional intervention.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of hypocalcemia following thyroid surgery, improving patient recovery and quality of life.
How similar studies have gone: Previous studies have indicated a potential link between vitamin D deficiency and postoperative hypocalcemia, suggesting that this approach may yield beneficial results.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Department of ENT and maxillofacial surgery
Corbeil-Essonnes, France Recruiting -
Department of Head and Neck Surgery and ENT
La Roche-sur-Yon, France Recruiting -
Hospital Poissy/Saint-Germain
Poissy, France Recruiting -
Hospital René Dubos,
Pontoise, France Recruiting -
Department of General, Digestive and Endocrine Surgery
Auxerre, France Terminated -
Hospital Lariboisière, Paris X
Paris, France Terminated
Study contacts
- Principal investigator: Dr Khaled AL TABAA — Hôpital NOVO
- Study coordinator: Maryline Delattre
- Email: maryline.delattre@ght-novo.fr
- Phone: +33 1 30 75 41 31
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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NIRAF-guided identification of parathyroids during thyroidectomy
A wearable near-infrared autofluorescence device is being tested to help surgeons find and protect the parathyroid glands during thyroid surgery in adults.
-
Low calcium after thyroid removal
This project will see if clinical, lab, and surgical factors predict low calcium after thyroid surgery in adults treated at Minia University Hospital from 2014–2024.
-
Using PTeye to help protect parathyroid glands during total thyroidectomy
This trial will test whether using the handheld PTeye device during total thyroidectomy in adults reduces the chance of low blood calcium after surgery.
-
Registry for patients with chronic hypoparathyroidism
This study looks at how living with chronic hypoparathyroidism affects patients' overall health and quality of life over time, by comparing their experiences with those of similar people without the condition.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.