NCT04094493

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Oct 2019

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

September 17, 2019

Last Update Submit

September 17, 2019

Conditions

Thyroid Diseases

Keywords

thyroid - thyroidectomy - hypocalcemia - Vit D administiration

Outcome Measures

Primary Outcomes (2)

  • Serum calcium level

    normal serum calcium level above 8.8 is the target

    2nd day post operatively

  • Appearance of hypocalcemic tetany

    numbness , tingling or carpopedal spasm are undesirable clinical presentation of hypocalcemia

    2nd day post operatively

Study Arms (4)

A1

EXPERIMENTAL

vit D + no hypocalcemia

Drug: vit D

A2

EXPERIMENTAL

Vit D + hypocalcemia

Drug: vit D

B1

NO INTERVENTION

NO vit D + no hypocalcemia

B2

NO INTERVENTION

NO vit D + hypocalcemia

Interventions

vit DDRUG

preoperative intra muscular vit D injection

A1A2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Low preoperative calcium level
  • Renal impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, 71511, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 31494332RESULT

  • 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.

    PMID: 30813146RESULT

  • 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.

    PMID: 31492617RESULT

  • 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.

    PMID: 26365947RESULT

  • 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.

    PMID: 23140919RESULT

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Central Study Contacts

Mohammed Ramadan

CONTACT

01024529525mhmdramdan93@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 19, 2019

Study Start

October 1, 2019

Primary Completion

July 1, 2020

Study Completion

September 30, 2020

Last Updated

September 19, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)