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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00630214

Enrollment

200

Registered

2008-03-06

Start date

2004-05-31

Completion date

2006-02-28

Last updated

2008-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypocalcemia

Keywords

Total thyroidectomy, CND, hypocalcemia, calcium, vitamin D

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTOral calcium plus vitamin D

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.

DIETARY_SUPPLEMENTOral calcium alone

calcium carbonate (3 g/day, 1 g every 8 h)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

15 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026