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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03777033
Enrollment
160
Registered
2018-12-17
Start date
2015-03-01
Completion date
2020-08-04
Last updated
2019-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Diseases

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

Interventions

DRUGProphylactic 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

Sponsors

Hellenic Red Cross Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

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 )

Eligibility

Sex/Gender
ALL
Age
15 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
blood calcium levels (mg/dl) on the 1st postoperative dayFrom the end of the operation until 24 hours after the operationblood calcium measured in a blood sample in mg/dl
blood calcium levels (mg/dl) on the 2nd postoperative dayFrom the end of the operation until 48 hours after the operationblood calcium measured in a blood sample in mg/dl
Length of hospital stay in daysFrom the day of the operation until a week after the operationhow many days the patient remained in the hospital

Secondary

MeasureTime frameDescription
Overall cost of the treatment ( euros)From the day of the operation until a month from the operationhow did this practice affected the cost of treatment of the patients

Countries

Greece

Contacts

Primary ContactSOPHOCLES LANITIS, M.D, PhD
drlanitis@yahoo.com00306974445355

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026