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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 : Active, not recruiting
First Posted : July 3, 2012
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Hypocalcemia Drug: Cholecalciferol Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Correction of Vitamin D Deficiency to Prevent Postoperative Hypocalcemia After Thyroidectomy
Study Start Date : June 2012
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
Drug: Cholecalciferol
100,000 U of cholecalciferol weekly for 4 weeks
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


Outcome Measures

Primary Outcome Measures :
  1. postoperative hypocalcemia [ Time Frame: up to 2 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632514


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

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
First Posted: July 3, 2012    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Debora Lucia Seguro Danilovic, University of Sao Paulo General Hospital:
hypocalcemia
vitamin D deficiency
cholecalciferol
thyroidectomy

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