Thyroid NeoplasmNCT03484416
Routine Calcium for Preventing Hypocalcemia
A study testing Calcium Carbonate 1500 Mg with Vitamin D in people with Thyroid Neoplasm, run by Ewha Womans University Mokdong Hospital at 1 site in South Korea.
Trial summary
The present study investigated the effect of routine calcium and vitamin D supplementation and tried to find the predictors for postoperative hypocalcemia in patients with thyroid cancer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Thyroid Neoplasm
- What is being tested?
- Calcium Carbonate 1500 Mg with Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2016to 30 May 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with thyroid cancer
- euthyroid state
- underwent total thyroidectomy
Who cannot join
- previous history of neck surgery or irradiation
- calcium supplement before enrollment
- hyperthyroidism or hypothyroidism
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Routine Low-dose Calcium and Vitamin D Supplementation for Preventing Symptomatic Postthyroidectomy Hypocalcemia
The present study investigated the effect of routine calcium and vitamin D supplementation and tried to find the predictors for postoperative hypocalcemia in patients with thyroid cancer.
Read the detailed description
The present study investigated the effect of routine calcium and vitamin D supplementation and tried to find the predictors for postoperative hypocalcemia in patients with thyroid cancer. Demographic data, including age, sex, pathologic features, and postoperative laboratory test results were analyzed, as was the development of symptomatic hypocalcemia, defined as an ionized calcium concentration below 4.6 mg/dL (normal range, 4.6-5.4 mg/dL) associated with hypocalcemic symptoms. Hypocalcemia was considered permanent in patients who required calcium supplementation for longer than 6 months after thyroidectomy.
Serum concentrations of PTH and ionized calcium were measured 1 and 14 days postoperatively. Patients in the routine calcium group received oral supplements of 1,500 mg/day elemental calcium and 1,000 IU/day cholecalciferol for 2 weeks, beginning on the first postoperative day (POD) to the 14th POD, whereas patients in the control group received no supplementation. If symptomatic hypocalcemia developed, patients in both groups received 2.0 g of intravenous calcium, followed by oral supplementation with 3,000-4,000 mg/day elemental calcium and 1,000-2,000 IU/day cholecalciferol up to the 14th POD. If hypocalcemic symptoms were persistent or worsening 2 hours after calcium administration, patients were administered another intravenous calcium supplementation.
- Conditions
- Thyroid Neoplasm
- Being tested
- Calcium Carbonate 1500 Mg with Vitamin D
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Carbonate 1500 Mg with Vitamin DDrug
Also called Dicamax 1000
Patients in the routine calcium group received oral supplements of 1,500 mg/day elemental calcium and 1,000 IU/day cholecalciferol (Dicamax 1000) for 2 weeks, whereas control group did not
| Study group | Role | What they receive |
|---|---|---|
| Routine calcium | Active comparator | Patients in the routine calcium group received oral supplements of 1,500 mg/day elemental calcium (by calcium carbonate) and 1,000 IU/day cholecalciferol for 2 weeks, beginning on the first postoperative day Receives: Drug: Calcium Carbonate 1500 Mg with Vitamin D |
| control | No intervention | Patients in the control group did not receive calcium or cholecalciferol for 2 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptomatic hypocalcemia
Symptomatic hypocalcemia was defined as an ionized calcium concentration below 4.6 mg/dL (normal range, 4.6-5.4 mg/dL) associated with hypocalcemic symptoms.
Measured: postoperative day 1
permanent hypocalcemia
Symptomatic hypocalcemia was defined as an ionized calcium concentration below 4.6 mg/dL (normal range, 4.6-5.4 mg/dL) associated with hypocalcemic symptoms.
Measured: postoperative 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start1 Mar 2016
- Primary completion30 May 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NeoplasmStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University Mokdong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyungju Kwon, Ewha Womans University Mokdong Hospital
- Investigators
- Hyungju Kwon, MD, Principal investigator, Ewah Womans University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484416
- Sponsor's protocol ID
- Rouine Calcium
- Status last verified
- Mar 2018
- First submitted
- 25 Mar 2018
- Last updated
- 30 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Low-dose Calcium and Vitamin D Supplementation for Preventing Symptomatic Postthyroidectomy Hypocalcemia
- ClinicalTrials.gov ID
- NCT03484416
- Acronym / sponsor ID
- Rouine Calcium
- Conditions
- Thyroid Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Ewha Womans University Mokdong HospitalUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 30 Mar 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.
The present study investigated the effect of routine calcium and vitamin D supplementation and tried to find the predictors for postoperative hypocalcemia in patients with thyroid cancer.
Detailed description
The present study investigated the effect of routine calcium and vitamin D supplementation and tried to find the predictors for postoperative hypocalcemia in patients with thyroid cancer. Demographic data, including age, sex, pathologic features, and postoperative laboratory test results were analyzed, as was the development of symptomatic hypocalcemia, defined as an ionized calcium concentration below 4.6 mg/dL (normal range, 4.6-5.4 mg/dL) associated with hypocalcemic symptoms. Hypocalcemia was considered permanent in patients who required calcium supplementation for longer than 6 months after thyroidectomy.
Serum concentrations of PTH and ionized calcium were measured 1 and 14 days postoperatively. Patients in the routine calcium group received oral supplements of 1,500 mg/day elemental calcium and 1,000 IU/day cholecalciferol for 2 weeks, beginning on the first postoperative day (POD) to the 14th POD, whereas patients in the control group received no supplementation. If symptomatic hypocalcemia developed, patients in both groups received 2.0 g of intravenous calcium, followed by oral supplementation with 3,000-4,000 mg/day elemental calcium and 1,000-2,000 IU/day cholecalciferol up to the 14th POD. If hypocalcemic symptoms were persistent or worsening 2 hours after calcium administration, patients were administered another intravenous calcium supplementation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine calcium | Active comparator | Drug: Calcium Carbonate 1500 Mg with Vitamin DPatients in the routine calcium group received oral supplements of 1,500 mg/day elemental calcium (by calcium carbonate) and 1,000 IU/day cholecalciferol for 2 weeks, beginning on the first postoperative day |
| control | No intervention | –Patients in the control group did not receive calcium or cholecalciferol for 2 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with thyroid cancer
- euthyroid state
- underwent total thyroidectomy
Key exclusion criteria (4 listed)
- previous history of neck surgery or irradiation
- calcium supplement before enrollment
- hyperthyroidism or hypothyroidism
- pregnancy
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 |
|---|---|---|
| Calcium Carbonate 1500 Mg with Vitamin DAlso: Dicamax 1000Patients in the routine calcium group received oral supplements of 1,500 mg/day elemental calcium and 1,000 IU/day cholecalciferol (Dicamax 1000) for 2 weeks, whereas control group did not | Drug | Routine calcium |
Primary outcome
symptomatic hypocalcemia
Time frame: postoperative day 1
Symptomatic hypocalcemia was defined as an ionized calcium concentration below 4.6 mg/dL (normal range, 4.6-5.4 mg/dL) associated with hypocalcemic symptoms.
permanent hypocalcemia
Time frame: postoperative 6 months
Symptomatic hypocalcemia was defined as an ionized calcium concentration below 4.6 mg/dL (normal range, 4.6-5.4 mg/dL) associated with hypocalcemic symptoms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Thyroid Neoplasm
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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.
Hyungju Kwon, MD principal investigator
Ewah Womans University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium Carbonate 1500 Mg with Vitamin D in people with Thyroid Neoplasm, run by Ewha Womans University Mokdong Hospital at 1 site in South Korea.
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 4 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: finished, as of the sponsor's last update on 30 Mar 2018. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptomatic hypocalcemia (time frame: postoperative day 1). The study lists 2 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 30 Mar 2018.