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Vitamin D Deficiency and Postoperative Hypocalcemia

Correction of Vitamin D Deficiency to Prevent Postoperative Hypocalcemia After Thyroidectomy

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01632514
Enrollment
90
Registered
2012-07-03
Start date
2012-06-30
Completion date
2017-06-30
Last updated
2016-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypocalcemia

Keywords

hypocalcemia, vitamin D deficiency, cholecalciferol, thyroidectomy

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.

Interventions

DRUGCholecalciferol

100,000 U of cholecalciferol weekly for 4 weeks

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
postoperative hypocalcemiaup to 2 days

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026