Clinical trial · Interventional
Phase II Pre-operative Vitamin D Supplementation to Prevent Post-thyroidectomy Hypocalcemia
A Phase 2, Placebo-controlled, Randomized Study to Evaluate the Effect of Pre-operative Vitamin D Supplementation on Hypocalcemia Following Total or Near-total Thyroidectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
One of the major side effects of surgery to remove the thyroid gland is transient (lasting for a short time) low calcium levels in the blood, or "hypocalcemia." Low calcium levels can cause symptoms such as numbness around the mouth, tingling or cramping in the hands and feet, severe muscle spasms, inability to breathe, or heart rhythm (heart beat) abnormalities. Severe symptoms are life threatening, so it is important to start the management of these symptoms in the hospital. Treating low calcium levels sometimes require patients to spend a few extra days in the hospital. The human body needs vitamin D to function and stay healthy. Vitamin D helps the body get the calcium needed to make strong bones and teeth. The purpose of this study is to determine if taking vitamin D before surgery to remove the thyroid gland affects whether or not you may have low calcium levels after your surgery and to test the hypothesis that those who are given the Vitamin D before surgery will have decreased hypocalcemia and a shortened hospital stay.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypocalcemia | — | UNRESOLVED | — |
| Thyroid Nodules | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calcitriol | Dietary Supplement | — | UNRESOLVED |
| Control Pill | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Vitamin D (Calcitriol)
- description
- Calcitriol, 1.0ug twice daily for 7 days prior to surgery
- interventionNames
- Dietary Supplement: Calcitriol
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- Placebo pill taken twice daily for 7 days prior to surgery
- interventionNames
- Dietary Supplement: Control Pill
Primary outcomes (1)
- measure
- Measure of Serum Calcium Levels
- timeFrame
- 2-5 days after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient referred for thyroidectomy * Agreement to use contraception prior to and during the study Exclusion Criteria: * Hypercalcemia (\>10.5mg/dL) * Chronic kidney or parathyroid disease * Cardiac or Central Nervous System disease * Pregnant or breastfeeding women
References
Publications (0)
Data not yet available