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

This study has been completed.
Sponsor:
Collaborator:
Chungnam National University
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00630214
First received: February 25, 2008
Last updated: March 5, 2008
Last verified: February 2008

February 25, 2008
March 5, 2008
May 2004
February 2006   (final data collection date for primary outcome measure)
The clinical utility of calcium and vitamin D supplements for prevention of hypocalcemia following total thyroidectomy plus central neck dissection [ Time Frame: To postoperative 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00630214 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Hypocalcemia
  • 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 Name: calcium carbonate and one-alpha (vitamin D)
  • Dietary Supplement: Oral calcium alone
    calcium carbonate (3 g/day, 1 g every 8 h)
    Other Name: calcium carbonate (Korea United Pharmaceutical Co, Seoul, Korea)
  • No Intervention: C
    No supplements after total thyroidectomy and central neck dissection
  • No Intervention: D
    No central neck dissection group (total thyroidectomy alone)
  • Active Comparator: A
    Oral calcium plus vitamin D supplements after total thyroidectomy and central neck dissection
    Intervention: Dietary Supplement: Oral calcium plus vitamin D
  • Active Comparator: B
    Oral calcium alone supplement after total thyroidectomy and central neck dissection
    Intervention: Dietary Supplement: Oral calcium alone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
February 2006
February 2006   (final data collection date for primary outcome measure)

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
Both
15 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00630214
2004-03-01
Yes
Jong-Lyel Roh, MD, PhD, Chungnam National University Hospital & Asan Medical Center
Asan Medical Center
Chungnam National University
Principal Investigator: Jong-Lyel Roh, MD, PhD Asan Medical Center & Chungnam National University Hospital
Asan Medical Center
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP