Clinical trial NCT03777033: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Diseases
Lead sponsor: Hellenic Red Cross Hospital
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 160
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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 )
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: blood calcium levels (mg/dl) on the 1st postoperative day
timeFrame: From the end of the operation until 24 hours after the operation
measure: blood calcium levels (mg/dl) on the 2nd postoperative day
timeFrame: From the end of the operation until 48 hours after the operation
measure: Length of hospital stay in days
timeFrame: From the day of the operation until a week after the operation
Secondary outcomes:
measure: Overall cost of the treatment ( euros)
timeFrame: From the day of the operation until a month from the operation
Other outcomes:
Locations:
city: Athens
country: Greece
facility: "Korgialenio-Benakio", Hellenic Red Cross Athens General Hospital,
Study officials:
affiliation: Korgiallenio benakeio hellenic red cross hospital
name: Sophocles Lanitis
role: PRINCIPAL_INVESTIGATOR
References: