An interventional study of Prophylactic protocol with Ca and Vit D in Thyroid Diseases, sponsored by Hellenic Red Cross Hospital. Status unknown at 1 site in Greece. Open to participants aged 15 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-06.
Sponsored by Hellenic Red Cross Hospital · Not applicable, Interventional, and Prevention
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.
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
976 studies on the registry are indexed under Thyroid Diseases; 197 are open to participants now.
This study's planned enrollment of 160 is above the median of 60 across 547 interventional studies indexed under Thyroid Diseases.
Browse Thyroid Diseases studies →Hellenic Red Cross Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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)
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
Also known as: one-alfa and mega calcium
blood calcium levels (mg/dl) on the 1st postoperative day
blood calcium measured in a blood sample in mg/dl
Time frame: 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
Time frame: 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
Time frame: From the day of the operation until a week after the operation
Overall cost of the treatment ( euros)
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
Plan to share: Undecided
Started Mar 2015 (actual). Primary completion is estimated for Apr 2020, 61 months after the start.
Of 149 non-industry interventional studies with no phase under Thyroid Diseases, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 66. This study's planned 61 months is above that.
Counting every sponsor, half of 152 studies reached it within 35 months; a quarter within 10 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Hellenic Red Cross Hospital