Systematic Administration of Calcium and Vitamin D After Thyroidectomy

Systematic Administration vs on Demand Administration of Calcium and Vitamin D After Thyroidectomy. A Randomized Control Trial

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.

Study Overview

• Status: Unknown
• Conditions: Thyroid Diseases
• Intervention / Treatment: Drug: Prophylactic protocol with Ca and Vit D

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

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: SOPHOCLES LANITIS, M.D, PhD; Phone Number: 00306974445355; Email: drlanitis@yahoo.com

Study Locations

• Greece
  • Athens, Greece, 11636
    • Recruiting
    • "Korgialenio-Benakio", Hellenic Red Cross Athens General Hospital,
    • Contact: SOPHOCLES LANITIS, MD, PhD; Phone Number: 6974445355; Email: drlanitis@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 90 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control Group; 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.
EXPERIMENTAL: Study group; 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)	Drug: Prophylactic protocol with Ca and Vit D; 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; Other Names: one-alfa and mega calcium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood calcium levels (mg/dl) on the 1st postoperative day	blood calcium measured in a blood sample in mg/dl	From the end of the operation until 24 hours after the operation
blood calcium levels (mg/dl) on the 2nd postoperative day	blood calcium measured in a blood sample in mg/dl	From the end of the operation until 48 hours after the operation
Length of hospital stay in days	how many days the patient remained in the hospital	From the day of the operation until a week after the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall cost of the treatment ( euros)	how did this practice affected the cost of treatment of the patients	From the day of the operation until a month from the operation

Collaborators and Investigators

• Sponsor: Hellenic Red Cross Hospital
• Investigators: Principal Investigator: Sophocles Lanitis, Korgiallenio benakeio hellenic red cross hospital

Publications and helpful links

Helpful Links

• Effectiveness of preventative and other surgical measures on hypocalcemia following bilateral thyroid surgery: a systematic review and meta-analysis.
• Role of postoperative vitamin D and/or calcium routine supplementation in preventing hypocalcemia after thyroidectomy: a systematic review and meta-analysis.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2015
• Primary Completion (ANTICIPATED): April 1, 2020
• Study Completion (ANTICIPATED): August 4, 2020

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (ACTUAL): December 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 3, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcium; Alfacalcidol
• Other Study ID Numbers: Ca/vitD in thyroidectomy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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