Trial | NCT00630214  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vitamin d3 calcium ...

  • Study Participants

    200
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.
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.
Study Started
May 31
2004
Primary Completion
Feb 28
2006
Study Completion
Feb 28
2006
Last Update
Mar 06
2008
Estimate

Dietary Supplement Oral calcium alone

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

  • Other names: calcium carbonate (Korea United Pharmaceutical Co, Seoul, Korea)

Dietary Supplement Oral 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.

  • Other names: calcium carbonate and one-alpha (vitamin D)

C No Intervention

No supplements after total thyroidectomy and central neck dissection

D No Intervention

No central neck dissection group (total thyroidectomy alone)

A Active Comparator

Oral calcium plus vitamin D supplements after total thyroidectomy and central neck dissection

B Active Comparator

Oral calcium alone supplement after total thyroidectomy and central neck dissection

Criteria 

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
No Results Posted