In current study, we aim to evaluate effect of preoperative vitamin D supplements administration effect in prevention of postoperative hypocalcemia in thyroidectomy patients with moderate and severe vitamin D deficiency. Of all patients with thyroidectomy indication referring to thoracic surgery clinic, during first visit, with due attention to serum vitamin D test results, 100 patients will enroll study and divide to case and control groups randomly. Afterward, case group patients will receive 50000 IU vitamin D supplement weekly up to 4 weeks, and control group patients will receive placebo in the same prescription. All patients will undergo thyroidectomy at the end of the 4th week. Subsequent to surgery, in order to evaluate postoperative hypocalcemia, serum total and ionized calcium levels will be checked in three period as follows: 6 to 12 hours after surgery, 18 to 24 hours after surgery and 48 to 72 hours after surgery. In addition, serum calcium levels will be checked at the end of the 2nd week postoperative to assess the long term hypocalcemia incidence in these patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062016077N6
Registration date:2016-06-29, 1395/04/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-29, 1395/04/09
Registrant information
Name
Ali Ramouz
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3441 3895
Email address
ali.ramouz@gmail.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of preoperative vitamin D supplementation on postoperative hypocalcemia in patients with vitamin D deficiency candidate for total thyroidectomy
Public title
Effect of vitamin D in prevention of postoperative hypocalcemia in total thyroidectomy patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: multi nodular goiter; thyroid cancers; patients candidates fo thyroidectomy who suffer moderate to severe vitamin D deficiency in preoperative tests.
Exclusion criteria:previous history of head and neck surgeries: coexisting parathyroid diseases; suffering diseases that affect calcium and vitamin D metabolism; patients who have injured or dissected parathyroid glands during surgery; patients who received vitamin supplements before surgery.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Sealed envelope method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the research and technology department, Tabriz University of Medical sciences
Street address
Research department- Ianeshgah street- Tabriz
City
Tabriz
Postal code
Approval date
2016-06-18, 1395/03/29
Ethics committee reference number
ir.tbzmed.rec.1395.214
Health conditions studied
1
Description of health condition studied
Postoperative hypocalcemia
ICD-10 code
E 89.0
ICD-10 code description
Postprocedural endocrine and metabolic disorders, not elsewhere classified
Primary outcomes
1
Description
Serum calcium level
Timepoint
Before surgery, 6 to 12 hours after surgery, 18 to 24 hours after surgery and 48 to 72 hours after surgery
Method of measurement
According to laboratory tests
Secondary outcomes
empty
Intervention groups
1
Description
Vitamin D 50000 IU weekly for 4 week administration in intervention group
Category
Treatment - Drugs
2
Description
Placebo administration instead of vitamin D in control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Taleghani hospital
Full name of responsible person
Seyed Ziaeddin Rasihashemi
Street address
City
Tabriz
2
Recruitment center
Name of recruitment center
Emma Reza hospital
Full name of responsible person
Seyed Ziaeddin Rasihashemi
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Ramouz
Street address
Imam Reza hospital, Daneshgah street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Ramouz
Position
medical student
Other areas of specialty/work
Street address
Imam Reza hospital, Daneshgah street
City
Tabriz
Postal code
Phone
+98 41 3441 3895
Fax
Email
ali.ramouz@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Seyed Ziaeddin Rasihashemi
Position
Assistant professor
Other areas of specialty/work
Street address
Imam Reza hospital
City
Tabriz
Postal code
Phone
+98 41 3441 3895
Fax
Email
ali.ramouz@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Ramouz
Position
Medical Student
Other areas of specialty/work
Street address
Imam Reza hospital, Daneshgah street
City
Tabriz
Postal code
Phone
+98 41 3441 3895
Fax
Email
ali.ramouz@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)