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Vit D Role in Post Thyroidectomy Hypocalcemia

Primary Purpose

Thyroid Diseases

Status
Unknown status
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
vit D
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thyroid Diseases focused on measuring thyroid - thyroidectomy - hypocalcemia - Vit D administiration

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • informed consent
  • patient age: > 18 years
  • surgical indication for total thyroidectomy
  • normal preoperative serum calcium level

Exclusion Criteria:

  • Low preoperative calcium level
  • Renal impairment

Sites / Locations

  • Assiut university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

No Intervention

No Intervention

Arm Label

A1

A2

B1

B2

Arm Description

vit D + no hypocalcemia

Vit D + hypocalcemia

NO vit D + no hypocalcemia

NO vit D + hypocalcemia

Outcomes

Primary Outcome Measures

Serum calcium level
normal serum calcium level above 8.8 is the target
Appearance of hypocalcemic tetany
numbness , tingling or carpopedal spasm are undesirable clinical presentation of hypocalcemia

Secondary Outcome Measures

Full Information

First Posted
September 17, 2019
Last Updated
September 17, 2019
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04094493
Brief Title
Vit D Role in Post Thyroidectomy Hypocalcemia
Official Title
Role of Pre Operative Vit D Administiration in Decrease Incidence of Post Thyroidectomy Hypocalcemia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Anticipated)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Hypocalcemia after total thyroidectomy is usually transient but it is of main concern as it requires either prolonged stay in the hospital or readmission. During the first 24 hours bleeding is the main complication, but from the second day to six months, transient hypocalcemia is of main concern. Hypocalcemia can be evaluated symptomatically as well as from laboratory testing. Signs and symptoms of hypocalcemia include numbness, tingling, and carpopedal spasm. Preoperative vitamin D prevents postoperative transient hypocalcemia after thyroidectomy .
Detailed Description
Thyroid surgery is one of the most frequently performed surgical procedures worldwide . Nowadays, total thyroidectomy is the recommended procedure for thyroid disease . As total thyroidectomy is the procedure of choice, the most common complication resulting after this surgery is transient hypocalcemia - the incidence being 24% - which increases the morbidity rate and increases the length of hospitalization . Other complications of thyroidectomy include recurrent laryngeal nerve injury which leads to hoarseness of voice, postoperative hemorrhage, dysphagia due to inflammation of the tissues surrounding the esophagus, seroma formation, Horner's syndrome due to injury to the cervical sympathetic chain, and poor healing of the wound with hypertrophy of the scar or wound infection . Advances in surgical techniques have evolved to preserve the parathyroid gland function, which helps to prevent permanent hypocalcemia and its incidence now has reduced to 1-2% . However, transient hypoparathyroidism still occurs resulting in transient hypocalcemia. It occurs due to the age, parathyroid gland handling, devascularization, venous congestion, post-surgical local site edema and neck dissection . Prescribing preoperative vitamin D and calcium decreases the incidence of transient hypocalcemia after total thyroidectomy from 25.9% to 6.8% as compared to the control group . Total thyroidectomy is the procedure of choice in our population with the preservation of the parathyroid gland. As transient hypocalcemia is common in post-thyroidectomy patients and increases the morbidity rate, giving vitamin D and calcium preoperatively can reduce the burden of postoperative transient hypocalcemia and it will be helpful in decreasing the morbidity rate due to post-thyroidectomy transient hypocalcemia. The objective of our study is to compare the frequency of transient hypocalcemia after vitamin D with the control group for patients undergoing total thyroidectomy. The study is based on patients with thyroid diseases who are indicated for total thyroidectomy . Patients are divided into two groups : group A who will recieve Vit D before operation and group B who won't . Group A will be divided into : A1 : no hypocacemia occurs with vit D A2 : hypocalcemia occurs with vit D . Group B will be divided into: B1 no hypocacemia without vit D B2 hypocalcemia without vit D . Comparison between the above mentioned four groups will determine the effectiveness of vit D in normalization of serum calcium levels after total thyroidectomy .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Diseases
Keywords
thyroid - thyroidectomy - hypocalcemia - Vit D administiration

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A1
Arm Type
Experimental
Arm Description
vit D + no hypocalcemia
Arm Title
A2
Arm Type
Experimental
Arm Description
Vit D + hypocalcemia
Arm Title
B1
Arm Type
No Intervention
Arm Description
NO vit D + no hypocalcemia
Arm Title
B2
Arm Type
No Intervention
Arm Description
NO vit D + hypocalcemia
Intervention Type
Drug
Intervention Name(s)
vit D
Intervention Description
preoperative intra muscular vit D injection
Primary Outcome Measure Information:
Title
Serum calcium level
Description
normal serum calcium level above 8.8 is the target
Time Frame
2nd day post operatively
Title
Appearance of hypocalcemic tetany
Description
numbness , tingling or carpopedal spasm are undesirable clinical presentation of hypocalcemia
Time Frame
2nd day post operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: informed consent patient age: > 18 years surgical indication for total thyroidectomy normal preoperative serum calcium level Exclusion Criteria: Low preoperative calcium level Renal impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed Ramadan
Phone
01024529525
Email
mhmdramdan93@gmail.com
Facility Information:
Facility Name
Assiut university
City
Assiut
ZIP/Postal Code
71511
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed Safwat
Phone
01025555420
Email
msafwat67@aun.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31494332
Citation
Khan Bhettani M, Rehman M, Ahmed M, Altaf HN, Choudry UK, Khan KH. Role of pre-operative vitamin D supplementation to reduce post-thyroidectomy hypocalcemia; Cohort study. Int J Surg. 2019 Nov;71:85-90. doi: 10.1016/j.ijsu.2019.08.035. Epub 2019 Sep 5.
Results Reference
result
PubMed Identifier
30813146
Citation
Xing T, Hu Y, Wang B, Zhu J. Role of oral calcium supplementation alone or with vitamin D in preventing post-thyroidectomy hypocalcaemia: A meta-analysis. Medicine (Baltimore). 2019 Feb;98(8):e14455. doi: 10.1097/MD.0000000000014455.
Results Reference
result
PubMed Identifier
31492617
Citation
Soares CSP, Tagliarini JV, Mazeto GMFS. Preoperative vitamin D level as a post-total thyroidectomy hypocalcemia predictor: a prospective study. Braz J Otorhinolaryngol. 2021 Jan-Feb;87(1):85-89. doi: 10.1016/j.bjorl.2019.07.001. Epub 2019 Aug 6.
Results Reference
result
PubMed Identifier
26365947
Citation
Cherian AJ, Ponraj S, Gowri S M, Ramakant P, Paul TV, Abraham DT, Paul MJ. The role of vitamin D in post-thyroidectomy hypocalcemia: Still an enigma. Surgery. 2016 Feb;159(2):532-8. doi: 10.1016/j.surg.2015.08.014. Epub 2015 Sep 11.
Results Reference
result
PubMed Identifier
23140919
Citation
Docimo G, Tolone S, Pasquali D, Conzo G, D'Alessandro A, Casalino G, Gili S, Brusciano L, Gubitosi A, Del Genio G, Ruggiero R, Docimo L. Role of pre and post-operative oral calcium and vitamin D supplements in prevention of hypocalcemia after total thyroidectomy. G Chir. 2012 Nov-Dec;33(11-12):374-8.
Results Reference
result

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Vit D Role in Post Thyroidectomy Hypocalcemia

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