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Vit D Role in Post Thyroidectomy Hypocalcemia

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ClinicalTrials.gov Identifier: NCT04094493
Recruitment Status : Not yet recruiting
First Posted : September 19, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed Ramadan, Assiut University

Study Description
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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 .

Condition or disease Intervention/treatment Phase
Thyroid Diseases Drug: vit D Early Phase 1

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 .

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Role of Pre Operative Vit D Administiration in Decrease Incidence of Post Thyroidectomy Hypocalcemia
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arms and Interventions
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Arm Intervention/treatment
Experimental: A1
vit D + no hypocalcemia
 Drug: vit D
preoperative intra muscular vit D injection
Experimental: A2
Vit D + hypocalcemia
 Drug: vit D
preoperative intra muscular vit D injection
No Intervention: B1
NO vit D + no hypocalcemia
No Intervention: B2
NO vit D + hypocalcemia


Outcome Measures
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Primary Outcome Measures :
  1. Serum calcium level [ Time Frame: 2nd day post operatively ]
    normal serum calcium level above 8.8 is the target

  2. Appearance of hypocalcemic tetany [ Time Frame: 2nd day post operatively ]
    numbness , tingling or carpopedal spasm are undesirable clinical presentation of hypocalcemia


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04094493


Contacts
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Contact: Mohammed Ramadan 01024529525 mhmdramdan93@gmail.com

Locations
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Egypt
Assiut university
Assiut, Egypt, 71511
Contact: Mohammed Safwat    01025555420    msafwat67@aun.edu.eg   
Sponsors and Collaborators
Assiut University
More Information
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Publications of Results:

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Responsible Party: Mohamed Ramadan, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT04094493    
Other Study ID Numbers: pre-thyroidectomy vit D
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Ramadan, Assiut University:
thyroid - thyroidectomy - hypocalcemia - Vit D administiration
Additional relevant MeSH terms:
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Hypocalcemia
Thyroid Diseases
Endocrine System Diseases
 Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance