Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitamin D Deficiency and Postoperative Hypocalcemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01632514
Recruitment Status : Unknown
Verified May 2016 by Debora Lucia Seguro Danilovic, University of Sao Paulo General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : July 3, 2012
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
Debora Lucia Seguro Danilovic, University of Sao Paulo General Hospital

Tracking Information
First Submitted Date  ICMJE June 26, 2012
First Posted Date  ICMJE July 3, 2012
Last Update Posted Date May 12, 2016
Study Start Date  ICMJE June 2012
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2012)
postoperative hypocalcemia [ Time Frame: up to 2 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01632514 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D Deficiency and Postoperative Hypocalcemia
Official Title  ICMJE Correction of Vitamin D Deficiency to Prevent Postoperative Hypocalcemia After Thyroidectomy
Brief Summary Hypocalcemia is a frequent adverse event after thyroidectomy. It is usually related to hypoparathyroidism, but preoperative hypocalcemia, hypomagnesemia or vitamin D deficiency contributes to it. This study aims to determine the frequency of vitamin D deficiency or insufficiency in patients submitted to thyroidectomy, to define the risk attributed to vitamin D deficiency to postoperative hypocalcemia, to identify other factors associated to postoperative calcium disorder, and to evaluate the benefit of preoperative treatment of vitamin D deficiency to prevent postoperative hypocalcemia.
Detailed Description Subjects to be submitted to total thyroidectomy will be included in the study. The investigators will evaluate serum levels of total calcium, ionic calcium, phosphorus, magnesium, creatinine, albumin, alkaline phosphatase, fasting glucose, thyroid stimulating hormone (TSH), free thyroxin (FT4), intact parathyroid hormone (PTH), 25 hydroxy vitamin D (25OHD), osteocalcin, C-terminal telopeptide (CTX) and procollagen type 1 amino-terminal propeptide (P1NP). Patients will be randomized to 3 groups: (1) 30 subjects with 25OHD < 20 ng/mL that will receive 100,000U of cholecalciferol weekly for 4 weeks before surgery, (2) 30 subjects with 25OHD < 20 ng/mL that will not receive cholecalciferol before surgery and (3) 30 controls with 25OHD >= 20 ng/mL that will not receive cholecalciferol before surgery. Afterwards, the investigators will evaluate immediate postoperative PTH and measure serum levels of total calcium, ionic calcium, magnesium, alkaline phosphatase, osteocalcin, CTX and P1NP in first and second postoperative days for further analysis.
Study Type  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Hypocalcemia
Intervention  ICMJE Drug: Cholecalciferol
100,000 U of cholecalciferol weekly for 4 weeks
Study Arms
  • Active Comparator: Vitamin D deficiency treatment
    subjects with 25OHD < 20 ng/mL that will receive 100,000U of cholecalciferol weekly for 4 weeks before surgery
    Intervention: Drug: Cholecalciferol
  • No Intervention: Vitamin D deficiency observation
    subjects with 25OHD < 20 ng/mL that will not receive cholecalciferol before surgery
  • No Intervention: Vitamin D sufficiency
    controls with 25OHD >= 20 ng/mL that will not receive cholecalciferol before surgery
Publications * Not Provided

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 28, 2012)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date June 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients that will be submitted to total thyroidectomy

Exclusion Criteria:

  • < 18 year-old
  • chronic renal failure (creatinine > 1.5 mg/dL)
  • fasting glucose > 200 mg/dl
  • albumin < 3.5 g/L
  • preoperative use of calcium supplements, bisphosphonates, corticosteroids
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01632514
Other Study ID Numbers  ICMJE USaoPauloGH 8624
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Debora Lucia Seguro Danilovic, University of Sao Paulo General Hospital
Study Sponsor  ICMJE University of Sao Paulo General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Debora LS Danilovic, M.D., PhD. University of Sao Paulo
PRS Account University of Sao Paulo General Hospital
Verification Date May 2016

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