<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03777033</url>
  </required_header>
  <id_info>
    <org_study_id>Ca/vitD in thyroidectomy</org_study_id>
    <nct_id>NCT03777033</nct_id>
  </id_info>
  <brief_title>Systematic Administration of Calcium and Vitamin D After Thyroidectomy</brief_title>
  <official_title>Systematic Administration vs on Demand Administration of Calcium and Vitamin D After Thyroidectomy. A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hellenic Red Cross Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hellenic Red Cross Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Transient hypocalcaemia consist the most common postoperative complication after&#xD;
      thyroidectomy (10-45%). It may be mild and subclinical or cause mild or severe symptoms and&#xD;
      may lead to longer hospital stay as well as in discomfort of the patients. For the management&#xD;
      oral or intravenous calcium with or without vitamin D administration can be used based on the&#xD;
      blood calcium levels and on the symptomatology. The investigators intent to study a new&#xD;
      protocol with oral calcium and vitamin D given systematically from the day of operation to&#xD;
      assess if this practice can minimize the rate of transient hypocalcaemia and as a consequence&#xD;
      minimize the length of stay in the hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Transient hypocalcaemia consist the most common postoperative complication after&#xD;
      thyroidectomy (10-45%). It may be mild and subclinical or cause mild or severe symptoms and&#xD;
      may lead to longer hospital stay as well as in discomfort of the patients. For the management&#xD;
      oral or intravenous calcium with or without vitamin D administration can be used based on the&#xD;
      blood calcium levels and on the symptomatology.&#xD;
&#xD;
      Group A = control group will be managed as usual. Oral or IV supplements of Calcium will be&#xD;
      giver on demand and recorded according to the clinical picture or the biochemical&#xD;
      hypocalcaemia.&#xD;
&#xD;
      Group B= study group will be given systematically from the day of operation a scheme with&#xD;
      oral calcium in the form of 1000ca++mg/tab and oral alfacalcidol in the form of 0.5&#xD;
      micrograms/tb The patients will receive one tablet three times a day oral calcium (3g/d) and&#xD;
      2 tablets , two times a day alfacalcidiol (2 micrograms/d) for the first 5 days. Afterwards&#xD;
      they will be taking 2 tablets a day of oral calcium ( 2g) and 2 tablets a day alfacalcidiol&#xD;
      (1micrograms/d) for another 10 days ( total 15 days) The investigators intent to minimize the&#xD;
      immediate transient hypocalcaemia rate and give time to the parathyroids which may have been&#xD;
      bruised or have compromised function initially to recover by day 15.&#xD;
&#xD;
      The 1st and 2nd postoperative day the invastigators are going to take blood samples and&#xD;
      assess the 25 hydroxy vit D, the parathyroid hormone (PTH) and the Ca++. The investigators&#xD;
      will also assess the calcium levels after the first week and if necessary ( in cases with&#xD;
      longstanding hypocalcaemia ) in later day.&#xD;
&#xD;
      The patients will be discharged from the hospital the day after the operation provided the&#xD;
      calcium levels are within normal range and they are completely asymptomatic.&#xD;
&#xD;
      In case of symptoms after the discharge the patients will be managed accordingly and this&#xD;
      will be recorded in the records of each patient&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2015</start_date>
  <completion_date type="Anticipated">August 4, 2020</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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 )</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>blood calcium levels (mg/dl) on the 1st postoperative day</measure>
    <time_frame>From the end of the operation until 24 hours after the operation</time_frame>
    <description>blood calcium measured in a blood sample in mg/dl</description>
  </primary_outcome>
  <primary_outcome>
    <measure>blood calcium levels (mg/dl) on the 2nd postoperative day</measure>
    <time_frame>From the end of the operation until 48 hours after the operation</time_frame>
    <description>blood calcium measured in a blood sample in mg/dl</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Length of hospital stay in days</measure>
    <time_frame>From the day of the operation until a week after the operation</time_frame>
    <description>how many days the patient remained in the hospital</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall cost of the treatment ( euros)</measure>
    <time_frame>From the day of the operation until a month from the operation</time_frame>
    <description>how did this practice affected the cost of treatment of the patients</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Thyroid Diseases</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prophylactic protocol with Ca and Vit D</intervention_name>
    <description>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&#xD;
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</description>
    <arm_group_label>Study group</arm_group_label>
    <other_name>one-alfa and mega calcium</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Thyroid pathology only&#xD;
&#xD;
          -  No calcium metabolism problems&#xD;
&#xD;
          -  Total / near total thyroidectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Renal failure,&#xD;
&#xD;
          -  Secondary hyperparathyroidism,&#xD;
&#xD;
          -  Primary hyperparathyroidism,&#xD;
&#xD;
          -  thyroid lobectomy,&#xD;
&#xD;
          -  Thyroid reoperation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sophocles Lanitis</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korgiallenio benakeio hellenic red cross hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>SOPHOCLES LANITIS, M.D, PhD</last_name>
    <phone>00306974445355</phone>
    <email>drlanitis@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>&quot;Korgialenio-Benakio&quot;, Hellenic Red Cross Athens General Hospital,</name>
      <address>
        <city>Athens</city>
        <zip>11636</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>SOPHOCLES LANITIS, MD, PhD</last_name>
      <phone>6974445355</phone>
      <email>drlanitis@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/25203484</url>
    <description>Effectiveness of preventative and other surgical measures on hypocalcemia following bilateral thyroid surgery: a systematic review and meta-analysis.</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/23635556</url>
    <description>Role of postoperative vitamin D and/or calcium routine supplementation in preventing hypocalcemia after thyroidectomy: a systematic review and meta-analysis.</description>
  </link>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>October 25, 2017</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>September 3, 2019</last_update_submitted>
  <last_update_submitted_qc>September 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hellenic Red Cross Hospital</investigator_affiliation>
    <investigator_full_name>Sophocles Lanitis</investigator_full_name>
    <investigator_title>M.D, PhD, Consultant in General Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alfacalcidol</mesh_term>
    <mesh_term>Calcium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03777033
org study id: Ca/vitD in thyroidectomy
nct id: NCT03777033
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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
allocation: Randomized
intervention model: Parallel Assignment
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
masking: Single (Outcomes Assessor)
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
description: blood calcium measured in a blood sample in mg/dl
measure: blood calcium levels (mg/dl) on the 2nd postoperative day
time frame: From the end of the operation until 48 hours after the operation
description: blood calcium measured in a blood sample in mg/dl
measure: Length of hospital stay in days
time frame: From the day of the operation until a week after the operation
description: how many days the patient remained in the hospital
measure: Overall cost of the treatment ( euros)
time frame: From the day of the operation until a month from the operation
description: how did this practice affected the cost of treatment of the patients
arm group label: Control Group
arm group type: No Intervention
description: 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.
arm group label: Study group
arm group type: Experimental
description: 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)
intervention type: Drug
intervention name: Prophylactic protocol with Ca and Vit D
description: 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
arm group label: Study group
other name: one-alfa and mega calcium
criteria: 
gender: All
minimum age: 15 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sophocles Lanitis
role: Principal Investigator
affiliation: Korgiallenio benakeio hellenic red cross hospital
last name: SOPHOCLES LANITIS, M.D, PhD
phone: 00306974445355
email: drlanitis@yahoo.com
facility: 
status: Recruiting
contact: 
country: Greece
url: https://www.ncbi.nlm.nih.gov/pubmed/25203484
description: Effectiveness of preventative and other surgical measures on hypocalcemia following bilateral thyroid surgery: a systematic review and meta-analysis.
url: https://www.ncbi.nlm.nih.gov/pubmed/23635556
description: Role of postoperative vitamin D and/or calcium routine supplementation in preventing hypocalcemia after thyroidectomy: a systematic review and meta-analysis.
responsible party type: Principal Investigator
investigator affiliation: Hellenic Red Cross Hospital
investigator full name: Sophocles Lanitis
investigator title: M.D, PhD, Consultant in General Surgery
mesh term: Thyroid Diseases
mesh term: Alfacalcidol
mesh term: Calcium
sharing ipd: Undecided