Vitamin D Deficiency and Postoperative Hypocalcemia
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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. 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypocalcemia |
Drug: Cholecalciferol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Correction of Vitamin D Deficiency to Prevent Postoperative Hypocalcemia After Thyroidectomy |
- postoperative hypocalcemia [ Time Frame: up to 2 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Study Start Date: | June 2012 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Vitamin D deficiency treatment |
Drug: Cholecalciferol
100,000 U of cholecalciferol weekly for 4 weeks
|
| No Intervention: Vitamin D deficiency observation | |
| No Intervention: Vitamin D sufficiency |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Debora LS Danilovic, M.D., PhD. | 55-11-26618456 | deboradanilovic@usp.br |
| Brazil | |
| Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | Recruiting |
| São Paulo, Brazil, 05403-010 | |
| Contact: Debora LS Danilovic, M.D., PhD. 55-11-26618456 deboradanilovic@usp.br | |
| Principal Investigator: Debora LS Danilovic, M.D., PhD. | |
| Principal Investigator: | Debora LS Danilovic, M.D., PhD. | Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo |
More Information
No publications provided
| Responsible Party: | Debora Lucia Seguro Danilovic, M.D., PhD., University of Sao Paulo General Hospital |
| ClinicalTrials.gov Identifier: | NCT01632514 History of Changes |
| Other Study ID Numbers: | USaoPauloGH 8624 |
| Study First Received: | June 26, 2012 |
| Last Updated: | June 28, 2012 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by University of Sao Paulo General Hospital:
|
hypocalcemia vitamin D deficiency cholecalciferol thyroidectomy |
Additional relevant MeSH terms:
|
Hypocalcemia Vitamin D Deficiency Calcium Metabolism Disorders Metabolic Diseases Water-Electrolyte Imbalance Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders |
Cholecalciferol Vitamin D Ergocalciferols Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on June 18, 2013