Vitamin D Deficiency and Postoperative Hypocalcemia

NCT ID: NCT01632514

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2017-06-30

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.

Conditions

Hypocalcemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Vitamin D deficiency treatment

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

Group Type: ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type: DRUG

100,000 U of cholecalciferol weekly for 4 weeks

Vitamin D deficiency observation

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Vitamin D sufficiency

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cholecalciferol

100,000 U of cholecalciferol weekly for 4 weeks

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Debora Lucia Seguro Danilovic

M.D., PhD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Debora LS Danilovic, M.D., PhD.

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

USaoPauloGH 8624

Identifier Type: -

Identifier Source: org_study_id