Effect of Vitamin D on Post-Thyroidectomy Hypocalcemia
Study of Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation
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 |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hôpital NOVO Academic / other |
| Locations | 6 sites (Auxerre and 5 other locations) |
| Trial ID | NCT04775381 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for a total thyroidectomy for any indication.
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.
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 performed: Previous studies have indicated a potential link between vitamin D deficiency and postoperative hypocalcemia, suggesting that this approach may yield beneficial results.
Eligibility criteria
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 this trial is running
Auxerre and 5 other locations
- Department of General, Digestive and Endocrine Surgery — Auxerre, France (Terminated)
- 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 Lariboisière, Paris X — Paris, France (Terminated)
- Hospital Poissy/Saint-Germain — Poissy, France (Recruiting)
- Hospital René Dubos, — Pontoise, France (Recruiting)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.