Prevention of Hypocalcemia in Patients Undergoing Total Thyroidectomy Plus Central Neck Dissection

Study Overview
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Brief Summary
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the increased risk of hypocalcemia following total thyroidectomy plus central neck dissection can be minimized by routine administration of oral calcium and vitamin D supplements during the early postoperative period.

Detailed Description
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Of patients with differentiated papillary thyroid carcinoma, group D underwent total thyroidectomy alone and groups A-C underwent total thyroidectomy plus CND. The latter were randomized to oral calcium (3 g/day) plus vitamin D (1 mcg/day) (group A, n = 49), calcium alone (group B, n = 49), or no supplements (group C, n = 50). Hypocalcemic symptoms, serum calcium, and parathyroid hormone (PTH) levels were compared among the groups.

Official Title
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Phase 2 Study of Routine Oral Calcium and Vitamine D Supplements to Prevent Hypocalcemia After Total Thyroidectomy in Papillary Thyroid Carcinoma Patients

Conditions
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Hypocalcemia

Intervention / Treatment
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* Dietary Supplement: Oral calcium plus vitamin D
* Dietary Supplement: Oral calcium alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Differentiated papillary thyroid carcinoma Undergoing total thyroidectomy plus central neck dissection Exclusion Criteria: Previous thyroid or neck surgery Patients with parathyroid diseases Other thyroid malignancies Early loss of follow-up without proper evaluation of postoperative serum calcium levels and symptoms

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: C<br>No supplements after total thyroidectomy and central neck dissection | |
| No Intervention: D<br>No central neck dissection group (total thyroidectomy alone) | |
| Active Comparator: A<br>Oral calcium plus vitamin D supplements after total thyroidectomy and central neck dissection | Dietary Supplement: Oral calcium plus vitamin D<br>* calcium supplementation took 3 g/day oral calcium (1 g every 8 h) plus 1 mcg/day vitamin D (0.5 mcg every 12 h), beginning on the night of surgery and continuing for 14 days.<br>* Other names: calcium carbonate and one-alpha (vitamin D);|
| Active Comparator: B<br>Oral calcium alone supplement after total thyroidectomy and central neck dissection | Dietary Supplement: Oral calcium alone<br>* calcium carbonate (3 g/day, 1 g every 8 h)<br>* Other names: calcium carbonate (Korea United Pharmaceutical Co, Seoul, Korea);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The clinical utility of calcium and vitamin D supplements for prevention of hypocalcemia following total thyroidectomy plus central neck dissection |  | To postoperative 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total thyroidectomy, CND, hypocalcemia, calcium, vitamin D