Vitamin D Deficiency and Postoperative Hypocalcemia

Phase 4

• Conditions: Hypocalcemia
• Interventions: Drug: Cholecalciferol

• Registration Number: NCT01632514
• Lead Sponsor: University of Sao Paulo General Hospital

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-07-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D deficiency treatment	Cholecalciferol	subjects with 25OHD \< 20 ng/mL that will receive 100,000U of cholecalciferol weekly for 4 weeks before surgery

Primary Outcome Measures

Name	Time	Method
postoperative hypocalcemia	up to 2 days

Trial Locations

Locations (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo; 🇧🇷 São Paulo, Brazil