Vitamin D Deficiency and Postoperative Hypocalcemia

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01632514

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypocalcemia	Drug: Cholecalciferol	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Correction of Vitamin D Deficiency to Prevent Postoperative Hypocalcemia After Thyroidectomy

Study Start Date :

Jun 1, 2012

Anticipated Primary Completion Date :

Jun 1, 2017

Anticipated Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vitamin D deficiency treatment subjects with 25OHD < 20 ng/mL that will receive 100,000U of cholecalciferol weekly for 4 weeks before surgery	Drug: Cholecalciferol 100,000 U of cholecalciferol weekly for 4 weeks
No Intervention: Vitamin D deficiency observation subjects with 25OHD < 20 ng/mL that will not receive cholecalciferol before surgery
No Intervention: Vitamin D sufficiency controls with 25OHD >= 20 ng/mL that will not receive cholecalciferol before surgery

Arm

Intervention/Treatment

Active Comparator: Vitamin D deficiency treatment

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

Drug: Cholecalciferol

100,000 U of cholecalciferol weekly for 4 weeks

No Intervention: Vitamin D deficiency observation

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

No Intervention: Vitamin D sufficiency

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

Outcome Measures

Primary Outcome Measures

postoperative hypocalcemia [up to 2 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo		Brazil	05403-010

Sponsors and Collaborators

University of Sao Paulo General Hospital

Investigators

Principal Investigator: Debora LS Danilovic, M.D., PhD., University of Sao Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Debora Lucia Seguro Danilovic, M.D., PhD., University of Sao Paulo General Hospital

ClinicalTrials.gov Identifier:

NCT01632514

Other Study ID Numbers:

USaoPauloGH 8624

First Posted:

Jul 3, 2012

Last Update Posted:

May 12, 2016

Last Verified:

May 1, 2016

Keywords provided by Debora Lucia Seguro Danilovic, M.D., PhD., University of Sao Paulo General Hospital

Additional relevant MeSH terms:

Study Results

No Results Posted as of May 12, 2016