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Systematic Administration of Calcium and Vitamin D After Thyroidectomy

Primary Purpose

Thyroid Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Prophylactic protocol with Ca and Vit D
Sponsored by
Hellenic Red Cross Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thyroid Diseases

Eligibility Criteria

15 Years - 90 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Thyroid pathology only
  • No calcium metabolism problems
  • Total / near total thyroidectomy

Exclusion Criteria:

  • Renal failure,
  • Secondary hyperparathyroidism,
  • Primary hyperparathyroidism,
  • thyroid lobectomy,
  • Thyroid reoperation

Sites / Locations

  • "Korgialenio-Benakio", Hellenic Red Cross Athens General Hospital,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Study group

Arm Description

Patients after thyroidectomy will be managed as usual. Oral or IV supplements of Calcium will be giver on demand and recorded according to the clinical picture or the biochemical hypocalcaemia.

Intervention: the patients will be given prophylactically ca and vit D. Patients after thyroidectomy will be given systematically from the day of operation a scheme with oral calcium in the form of 1000ca++mg/tab and oral alfacalcidol in the form of 0.5 micrograms/tb Intervention: The patients will receive one tablet three times a day oral calcium (3g/d) and 2 tablets , two times a day alfacalcidiol (2 micrograms/d) for the first 5 days. Afterwards they will be taking 2 tablets a day of oral calcium ( 2g) and 2 tablets a day alfacalcidiol (1micrograms/d) for another 10 days ( total 15 days)

Outcomes

Primary Outcome Measures

blood calcium levels (mg/dl) on the 1st postoperative day
blood calcium measured in a blood sample in mg/dl
blood calcium levels (mg/dl) on the 2nd postoperative day
blood calcium measured in a blood sample in mg/dl
Length of hospital stay in days
how many days the patient remained in the hospital

Secondary Outcome Measures

Overall cost of the treatment ( euros)
how did this practice affected the cost of treatment of the patients

Full Information

First Posted
October 25, 2017
Last Updated
September 3, 2019
Sponsor
Hellenic Red Cross Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03777033
Brief Title
Systematic Administration of Calcium and Vitamin D After Thyroidectomy
Official Title
Systematic Administration vs on Demand Administration of Calcium and Vitamin D After Thyroidectomy. A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
April 1, 2020 (Anticipated)
Study Completion Date
August 4, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hellenic Red Cross Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Transient hypocalcaemia consist the most common postoperative complication after thyroidectomy (10-45%). It may be mild and subclinical or cause mild or severe symptoms and may lead to longer hospital stay as well as in discomfort of the patients. For the management oral or intravenous calcium with or without vitamin D administration can be used based on the blood calcium levels and on the symptomatology. The investigators intent to study a new protocol with oral calcium and vitamin D given systematically from the day of operation to assess if this practice can minimize the rate of transient hypocalcaemia and as a consequence minimize the length of stay in the hospital.
Detailed Description
Transient hypocalcaemia consist the most common postoperative complication after thyroidectomy (10-45%). It may be mild and subclinical or cause mild or severe symptoms and may lead to longer hospital stay as well as in discomfort of the patients. For the management oral or intravenous calcium with or without vitamin D administration can be used based on the blood calcium levels and on the symptomatology. Group A = control group will be managed as usual. Oral or IV supplements of Calcium will be giver on demand and recorded according to the clinical picture or the biochemical hypocalcaemia. Group B= study group will be given systematically from the day of operation a scheme with oral calcium in the form of 1000ca++mg/tab and oral alfacalcidol in the form of 0.5 micrograms/tb The patients will receive one tablet three times a day oral calcium (3g/d) and 2 tablets , two times a day alfacalcidiol (2 micrograms/d) for the first 5 days. Afterwards they will be taking 2 tablets a day of oral calcium ( 2g) and 2 tablets a day alfacalcidiol (1micrograms/d) for another 10 days ( total 15 days) The investigators intent to minimize the immediate transient hypocalcaemia rate and give time to the parathyroids which may have been bruised or have compromised function initially to recover by day 15. The 1st and 2nd postoperative day the invastigators are going to take blood samples and assess the 25 hydroxy vit D, the parathyroid hormone (PTH) and the Ca++. The investigators will also assess the calcium levels after the first week and if necessary ( in cases with longstanding hypocalcaemia ) in later day. The patients will be discharged from the hospital the day after the operation provided the calcium levels are within normal range and they are completely asymptomatic. In case of symptoms after the discharge the patients will be managed accordingly and this will be recorded in the records of each patient

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial - control group ( supplements of calcium and vit D on demand) vs study group ( systematic administration of oral calcium and vit D )
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients after thyroidectomy will be managed as usual. Oral or IV supplements of Calcium will be giver on demand and recorded according to the clinical picture or the biochemical hypocalcaemia.
Arm Title
Study group
Arm Type
Experimental
Arm Description
Intervention: the patients will be given prophylactically ca and vit D. Patients after thyroidectomy will be given systematically from the day of operation a scheme with oral calcium in the form of 1000ca++mg/tab and oral alfacalcidol in the form of 0.5 micrograms/tb Intervention: The patients will receive one tablet three times a day oral calcium (3g/d) and 2 tablets , two times a day alfacalcidiol (2 micrograms/d) for the first 5 days. Afterwards they will be taking 2 tablets a day of oral calcium ( 2g) and 2 tablets a day alfacalcidiol (1micrograms/d) for another 10 days ( total 15 days)
Intervention Type
Drug
Intervention Name(s)
Prophylactic protocol with Ca and Vit D
Other Intervention Name(s)
one-alfa and mega calcium
Intervention Description
3g calcium /day for 5 days and then 2g/day for 10 days 2 Micrograms Alfacalcidol/day and then 1 microgram /day for 10 days the Prophylactic protocol with Ca and Vit D will be given in the form of Alfacalcidol 0.5 Micrograms Capsule and CALCIUM CARBONATE + CALCIUM GALACTOGLUCONATE 1000mg tablet
Primary Outcome Measure Information:
Title
blood calcium levels (mg/dl) on the 1st postoperative day
Description
blood calcium measured in a blood sample in mg/dl
Time Frame
From the end of the operation until 24 hours after the operation
Title
blood calcium levels (mg/dl) on the 2nd postoperative day
Description
blood calcium measured in a blood sample in mg/dl
Time Frame
From the end of the operation until 48 hours after the operation
Title
Length of hospital stay in days
Description
how many days the patient remained in the hospital
Time Frame
From the day of the operation until a week after the operation
Secondary Outcome Measure Information:
Title
Overall cost of the treatment ( euros)
Description
how did this practice affected the cost of treatment of the patients
Time Frame
From the day of the operation until a month from the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Thyroid pathology only No calcium metabolism problems Total / near total thyroidectomy Exclusion Criteria: Renal failure, Secondary hyperparathyroidism, Primary hyperparathyroidism, thyroid lobectomy, Thyroid reoperation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SOPHOCLES LANITIS, M.D, PhD
Phone
00306974445355
Email
drlanitis@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophocles Lanitis
Organizational Affiliation
Korgiallenio benakeio hellenic red cross hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
"Korgialenio-Benakio", Hellenic Red Cross Athens General Hospital,
City
Athens
ZIP/Postal Code
11636
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SOPHOCLES LANITIS, MD, PhD
Phone
6974445355
Email
drlanitis@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/25203484
Description
Effectiveness of preventative and other surgical measures on hypocalcemia following bilateral thyroid surgery: a systematic review and meta-analysis.
URL
https://www.ncbi.nlm.nih.gov/pubmed/23635556
Description
Role of postoperative vitamin D and/or calcium routine supplementation in preventing hypocalcemia after thyroidectomy: a systematic review and meta-analysis.

Learn more about this trial

Systematic Administration of Calcium and Vitamin D After Thyroidectomy

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