Vitamin D Deficiency and Postoperative Hypocalcemia

NCT01632514 | Unknown Phase 4

• 1 other identifier: USaoPauloGH 8624
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypocalcemia

Keywords

hypocalcemia; vitamin D deficiency; cholecalciferol; thyroidectomy

Outcome Measures

Primary Outcomes (1)

• postoperative hypocalcemia

  up to 2 days

Study Arms (3)

Vitamin D deficiency treatment

ACTIVE COMPARATOR

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

Drug: Cholecalciferol

Vitamin D deficiency observation

NO INTERVENTION

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

Vitamin D sufficiency

NO INTERVENTION

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

Interventions

Cholecalciferol DRUG

100,000 U of cholecalciferol weekly for 4 weeks

Vitamin D deficiency treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients that will be submitted to total thyroidectomy

You may not qualify if:

• \< 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, 05403-010, Brazil

Location

MeSH Terms

Conditions

Hypocalcemia; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Debora LS Danilovic, M.D., PhD.

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD.

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: July 3, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

BR (1)