Overview

This trial is active, not recruiting.

Condition hypocalcemia
Treatment cholecalciferol
Phase phase 4
Sponsor University of Sao Paulo General Hospital
Start date June 2012
End date June 2015
Trial size 90 participants
Trial identifier NCT01632514, USaoPauloGH 8624

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
subjects with 25OHD < 20 ng/mL that will receive 100,000U of cholecalciferol weekly for 4 weeks before surgery
cholecalciferol Cholecalciferol
100,000 U of cholecalciferol weekly for 4 weeks
(No Intervention)
subjects with 25OHD < 20 ng/mL that will not receive cholecalciferol before surgery
(No Intervention)
controls with 25OHD >= 20 ng/mL that will not receive cholecalciferol before surgery

Primary Outcomes

Measure
postoperative hypocalcemia
time frame: up to 2 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Correction of Vitamin D Deficiency to Prevent Postoperative Hypocalcemia After Thyroidectomy
Principal investigator Debora LS Danilovic, M.D., PhD.
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University of Sao Paulo General Hospital.