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

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ClinicalTrials.gov Identifier: NCT00630214
Recruitment Status : Completed
First Posted : March 6, 2008
Last Update Posted : March 6, 2008
Sponsor:
Collaborator:
Chungnam National University
Information provided by:
Asan Medical Center

Tracking Information
First Submitted Date  ICMJE February 25, 2008
First Posted Date  ICMJE March 6, 2008
Last Update Posted Date March 6, 2008
Study Start Date  ICMJE May 2004
Actual Primary Completion Date February 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Hypocalcemia in Patients Undergoing Total Thyroidectomy Plus Central Neck Dissection
Official Title  ICMJE Phase 2 Study of Routine Oral Calcium and Vitamine D Supplements to Prevent Hypocalcemia After Total Thyroidectomy in Papillary Thyroid Carcinoma Patients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Hypocalcemia
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2008)
200
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2006
Actual Primary Completion Date February 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 85 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00630214
Other Study ID Numbers  ICMJE 2004-03-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jong-Lyel Roh, MD, PhD, Chungnam National University Hospital & Asan Medical Center
Study Sponsor  ICMJE Asan Medical Center
Collaborators  ICMJE Chungnam National University
Investigators  ICMJE
Principal Investigator: Jong-Lyel Roh, MD, PhD Asan Medical Center & Chungnam National University Hospital
PRS Account Asan Medical Center
Verification Date February 2008

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