Thyroid DiseasesNCT03777033
Systematic Administration of Calcium and Vitamin D After Thyroidectomy
A study testing Prophylactic protocol with Ca and Vit D in people with Thyroid Diseases, run by Hellenic Red Cross Hospital at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Diseases
- What is being tested?
- Prophylactic protocol with Ca and Vit D
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteGreece
- Study dates
- 1 Mar 2015to 4 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Thyroid pathology only
- No calcium metabolism problems
- Total / near total thyroidectomy
Who cannot join
- Renal failure,
- Secondary hyperparathyroidism,
- Primary hyperparathyroidism,
- thyroid lobectomy,
- Thyroid reoperation
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
"Korgialenio-Benakio", Hellenic Red Cross Athens General Hospital,
Athens, 11636
SOPHOCLES LANITIS, MD, PhD, 6974445355, drlanitis@yahoo.com
About this study
Official title: 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.
Read the 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
- Conditions
- Thyroid Diseases
- Being tested
- Prophylactic protocol with Ca and Vit D
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic protocol with Ca and Vit DDrug
Also called one-alfa and mega calcium
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
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | 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. |
| Study group | Experimental | 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) Receives: Drug: Prophylactic protocol with Ca and Vit D |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood calcium levels (mg/dl) on the 1st postoperative day
blood calcium measured in a blood sample in mg/dl
Measured: 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
Measured: 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
Measured: From the day of the operation until a week after the operation
Secondary outcomes (1)
Overall cost of the treatment ( euros)
how did this practice affected the cost of treatment of the patients
Measured: From the day of the operation until a month from the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start1 Mar 2015
- Primary completion1 Apr 2020 (estimated)
- Study completion4 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hellenic Red Cross Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sophocles Lanitis, Hellenic Red Cross Hospital
- Investigators
- Sophocles Lanitis, Principal investigator, Korgiallenio benakeio hellenic red cross hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777033
- Sponsor's protocol ID
- Ca/vitD in thyroidectomy
- Status last verified
- Sep 2019
- First submitted
- 25 Oct 2017
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Administration vs on Demand Administration of Calcium and Vitamin D After Thyroidectomy. A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03777033
- Acronym / sponsor ID
- Ca/vitD in thyroidectomy
- Conditions
- Thyroid Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hellenic Red Cross HospitalUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 4 Aug 2020 (estimated)
- First posted
- 17 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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 )
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –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. |
| Study group | Experimental | Drug: Prophylactic protocol with Ca and Vit DIntervention: 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) |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Thyroid pathology only
- No calcium metabolism problems
- Total / near total thyroidectomy
Key exclusion criteria (5 listed)
- Renal failure,
- Secondary hyperparathyroidism,
- Primary hyperparathyroidism,
- thyroid lobectomy,
- Thyroid reoperation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prophylactic protocol with Ca and Vit DAlso: one-alfa and mega calcium3g 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 | Drug | Study group |
Primary outcome
blood calcium levels (mg/dl) on the 1st postoperative day
Time frame: From the end of the operation until 24 hours after the operation
blood calcium measured in a blood sample in mg/dl
blood calcium levels (mg/dl) on the 2nd postoperative day
Time frame: From the end of the operation until 48 hours after the operation
blood calcium measured in a blood sample in mg/dl
Length of hospital stay in days
Time frame: From the day of the operation until a week after the operation
how many days the patient remained in the hospital
1 secondary outcome
Overall cost of the treatment ( euros)
Time frame: From the day of the operation until a month from the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Effectiveness of preventative and other surgical measures on hypocalcemia following bilateral thyroid surgery: a systematic review and meta-analysis.Link provided by the sponsor.
- Role of postoperative vitamin D and/or calcium routine supplementation in preventing hypocalcemia after thyroidectomy: a systematic review and meta-analysis.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Thyroid Diseases
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophocles Lanitis principal investigator
Korgiallenio benakeio hellenic red cross hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic protocol with Ca and Vit D in people with Thyroid Diseases, run by Hellenic Red Cross Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SOPHOCLES LANITIS, M.D, PhD (00306974445355, drlanitis@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood calcium levels (mg/dl) on the 1st postoperative day (time frame: From the end of the operation until 24 hours after the operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.