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Vitamin D Deficiency and Postoperative Hypocalcemia

Primary Purpose

Hypocalcemia

Status

Unknown status

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Cholecalciferol

About this trial

This is an interventional prevention trial for Hypocalcemia focused on measuring hypocalcemia, vitamin D deficiency, cholecalciferol, thyroidectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

Vitamin D deficiency treatment

Vitamin D deficiency observation

Vitamin D sufficiency

Arm Description

subjects with 25OHD < 20 ng/mL that will receive 100,000U of cholecalciferol weekly for 4 weeks before surgery

subjects with 25OHD < 20 ng/mL that will not receive cholecalciferol before surgery

controls with 25OHD >= 20 ng/mL that will not receive cholecalciferol before surgery

Outcomes

Primary Outcome Measures

postoperative hypocalcemia

Secondary Outcome Measures

Full Information

NCT ID

NCT01632514

First Posted

June 26, 2012

Last Updated

May 10, 2016

Sponsor

University of Sao Paulo General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01632514

Brief Title

Vitamin D Deficiency and Postoperative Hypocalcemia

Official Title

Correction of Vitamin D Deficiency to Prevent Postoperative Hypocalcemia After Thyroidectomy

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Unknown status

Study Start Date

June 2012 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypocalcemia

Keywords

hypocalcemia, vitamin D deficiency, cholecalciferol, thyroidectomy

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D deficiency treatment

Arm Type

Active Comparator

Arm Description

subjects with 25OHD < 20 ng/mL that will receive 100,000U of cholecalciferol weekly for 4 weeks before surgery

Arm Title

Vitamin D deficiency observation

Arm Type

No Intervention

Arm Description

subjects with 25OHD < 20 ng/mL that will not receive cholecalciferol before surgery

Arm Title

Vitamin D sufficiency

Arm Type

No Intervention

Arm Description

controls with 25OHD >= 20 ng/mL that will not receive cholecalciferol before surgery

Intervention Type

Drug

Intervention Name(s)

Cholecalciferol

Intervention Description

100,000 U of cholecalciferol weekly for 4 weeks

Primary Outcome Measure Information:

Title

postoperative hypocalcemia

Time Frame

up to 2 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Debora LS Danilovic, M.D., PhD.

Organizational Affiliation

University of Sao Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

City

São Paulo

ZIP/Postal Code

05403-010

Country

Brazil

12. IPD Sharing Statement

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Vitamin D Deficiency and Postoperative Hypocalcemia

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