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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01632514
Other study ID # USaoPauloGH 8624
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received June 26, 2012
Last updated December 5, 2014
Start date June 2012
Est. completion date June 2015

Study information

Verified date December 2014
Source University of Sao Paulo General Hospital
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 90
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Cholecalciferol
100,000 U of cholecalciferol weekly for 4 weeks

Locations

Country Name City State
Brazil Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative hypocalcemia up to 2 days No
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