Vitamin D Deficiency and Postoperative Hypocalcemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Sao Paulo General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Debora Lucia Seguro Danilovic, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01632514
First received: June 26, 2012
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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. 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.


Condition Intervention Phase
Hypocalcemia
Drug: Cholecalciferol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Correction of Vitamin D Deficiency to Prevent Postoperative Hypocalcemia After Thyroidectomy

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • postoperative hypocalcemia [ Time Frame: up to 2 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: June 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D deficiency treatment Drug: Cholecalciferol
100,000 U of cholecalciferol weekly for 4 weeks
No Intervention: Vitamin D deficiency observation
No Intervention: Vitamin D sufficiency

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01632514

Contacts
Contact: Debora LS Danilovic, M.D., PhD. 55-11-26618456 deboradanilovic@usp.br

Locations
Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo Recruiting
São Paulo, Brazil, 05403-010
Contact: Debora LS Danilovic, M.D., PhD.    55-11-26618456    deboradanilovic@usp.br   
Principal Investigator: Debora LS Danilovic, M.D., PhD.         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Debora LS Danilovic, M.D., PhD. Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
  More Information

No publications provided

Responsible Party: Debora Lucia Seguro Danilovic, M.D., PhD., University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01632514     History of Changes
Other Study ID Numbers: USaoPauloGH 8624
Study First Received: June 26, 2012
Last Updated: June 28, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo General Hospital:
hypocalcemia
vitamin D deficiency
cholecalciferol
thyroidectomy

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

ClinicalTrials.gov processed this record on July 26, 2014