Trial record 2 of 21 for:    Open Studies | "Hypocalcemia"

Preoperative Vitamin D for Post-thyroidectomy Hypocalcemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University of Alberta.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Caroline Xu, University of Alberta
ClinicalTrials.gov Identifier:
NCT01609439
First received: May 24, 2012
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

The purpose of this study is to determine if pre-operative vitamin D supplementation lowers the incidence of post-operative transient or permanent hypoparathyroidism in patients undergoing total thyroidectomy.


Condition Intervention
Hypocalcemia
Drug: Vitamin D
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pre-operative Vitamin D Supplementation to Reduce Post-operative Hypocalcemia in Patients Undergoing Total Thyroidectomy: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Hypocalcemia [ Time Frame: Transient (<72 hrs post-operatively) ] [ Designated as safety issue: No ]
    Clinical signs and symptoms(paraesthesias, etc.) OR Laboratory evidence (ICa < 0.9) Need for IV calcium supplementation


Secondary Outcome Measures:
  • Hypocalcemia [ Time Frame: Permanent (>4 weeks) ] [ Designated as safety issue: No ]
    ICa at 6 weeks and need for continued supplementation beyond 6 weeks post-op (i.e. 3 months follow-up post-operatively)


Estimated Enrollment: 110
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo
Experimental: Treatment
Pre-operative Vitamin D 800 units x 4 weeks
Drug: Vitamin D
Vitamin D 800 units for 4 weeks preoperatively

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients undergoing total thyroidecomty +/- CND
  • Adult (age > or = 18)

Exclusion Criteria:

  • Known chronic kidney disease
  • Known primary hyper or hypoparathyroidism
  • Known hypoalbuminemia
  • Concurrent use medications affecting calcium metabolism
  • Completion hemithyroidectomy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609439

Contacts
Contact: Caroline C Xu, MD 7809694655 cxu@ualberta.ca

Locations
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Caroline C Xu, MD    7809694655    cxu@ualberta.ca   
Sponsors and Collaborators
University of Alberta
  More Information

No publications provided

Responsible Party: Caroline Xu, Resident, Otolaryngology-Head and Neck Surgery, University of Alberta
ClinicalTrials.gov Identifier: NCT01609439     History of Changes
Other Study ID Numbers: UAH-Oto-TT01
Study First Received: May 24, 2012
Last Updated: May 29, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
Permanent
temporary
hypocalcemia

Additional relevant MeSH terms:
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 22, 2014