HypocalcemiaPhase 2NCT00630214
Prevention of Hypocalcemia in Patients Undergoing Total Thyroidectomy Plus Central Neck Dissection
A Phase 2 study testing Oral calcium plus vitamin D and Oral calcium alone in people with Hypocalcemia, run by Asan Medical Center at 1 site in South Korea.
Trial summary
the increased risk of hypocalcemia following total thyroidectomy plus central neck dissection can be minimized by routine administration of oral calcium and vitamin D supplements during the early postoperative period. Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Hypocalcemia
- What is being tested?
- Oral calcium plus vitamin D and Oral calcium alone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2004to Feb 2006
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Differentiated papillary thyroid carcinoma
- Undergoing total thyroidectomy plus central neck dissection
Who cannot join
- Previous thyroid or neck surgery
- Patients with parathyroid diseases
- Other thyroid malignancies
- Early loss of follow-up without proper evaluation of postoperative serum calcium levels and symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Routine Oral Calcium and Vitamine D Supplements to Prevent Hypocalcemia After Total Thyroidectomy in Papillary Thyroid Carcinoma Patients
the increased risk of hypocalcemia following total thyroidectomy plus central neck dissection can be minimized by routine administration of oral calcium and vitamin D supplements during the early postoperative period.
Read the detailed description
Of patients with differentiated papillary thyroid carcinoma, group D underwent total thyroidectomy alone and groups A-C underwent total thyroidectomy plus CND. The latter were randomized to oral calcium (3 g/day) plus vitamin D (1 mcg/day) (group A, n = 49), calcium alone (group B, n = 49), or no supplements (group C, n = 50). Hypocalcemic symptoms, serum calcium, and parathyroid hormone (PTH) levels were compared among the groups.
- Conditions
- Hypocalcemia
- Being tested
- Oral calcium plus vitamin D, Oral calcium alone
- Keywords
- Total thyroidectomy, CND, hypocalcemia, calcium, vitamin D
- Medical subject headings
- Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral calcium plus vitamin DDietary supplement
Also called calcium carbonate and one-alpha (vitamin D)
calcium supplementation took 3 g/day oral calcium (1 g every 8 h) plus 1 mcg/day vitamin D (0.5 mcg every 12 h), beginning on the night of surgery and continuing for 14 days.
Oral calcium aloneDietary supplement
Also called calcium carbonate (Korea United Pharmaceutical Co, Seoul, Korea)
calcium carbonate (3 g/day, 1 g every 8 h)
| Study group | Role | What they receive |
|---|---|---|
| C | No intervention | No supplements after total thyroidectomy and central neck dissection |
| D | No intervention | No central neck dissection group (total thyroidectomy alone) |
| A | Active comparator | Oral calcium plus vitamin D supplements after total thyroidectomy and central neck dissection Receives: Dietary Supplement: Oral calcium plus vitamin D |
| B | Active comparator | Oral calcium alone supplement after total thyroidectomy and central neck dissection Receives: Dietary Supplement: Oral calcium alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical utility of calcium and vitamin D supplements for prevention of hypocalcemia following total thyroidectomy plus central neck dissection
Measured: To postoperative 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startMay 2004
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypocalcemiaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Chungnam National University
- Investigators
- Jong-Lyel Roh, MD, PhD, Principal investigator, Asan Medical Center & Chungnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630214
- Sponsor's protocol ID
- 2004-03-01
- Status last verified
- Feb 2008
- First submitted
- 25 Feb 2008
- Last updated
- 6 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bellantone R, Lombardi CP, Raffaelli M, Boscherini M, Alesina PF, De Crea C, Traini E, Princi P. Is routine supplementation therapy (calcium and vitamin D) useful after total thyroidectomy? Surgery. 2002 Dec;132(6):1109-12; discussion 1112-3. doi: 10.1067/msy.2002.128617.
PubMed 12490862Moore FD Jr. Oral calcium supplements to enhance early hospital discharge after bilateral surgical treatment of the thyroid gland or exploration of the parathyroid glands. J Am Coll Surg. 1994 Jan;178(1):11-6.
PubMed 8156110Roh JL, Park JY, Park CI. Prevention of postoperative hypocalcemia with routine oral calcium and vitamin D supplements in patients with differentiated papillary thyroid carcinoma undergoing total thyroidectomy plus central neck dissection. Cancer. 2009 Jan 15;115(2):251-8. doi: 10.1002/cncr.24027.
PubMed 19117033
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Routine Oral Calcium and Vitamine D Supplements to Prevent Hypocalcemia After Total Thyroidectomy in Papillary Thyroid Carcinoma Patients
- ClinicalTrials.gov ID
- NCT00630214
- Acronym / sponsor ID
- 2004-03-01
- Conditions
- Hypocalcemia
- Keywords
- Total thyroidectomy, CND, hypocalcemia, calcium, vitamin D
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Chungnam National University
- Study start
- May 2004
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 6 Mar 2008 (estimated)
- 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 increased risk of hypocalcemia following total thyroidectomy plus central neck dissection can be minimized by routine administration of oral calcium and vitamin D supplements during the early postoperative period.
Detailed description
Of patients with differentiated papillary thyroid carcinoma, group D underwent total thyroidectomy alone and groups A-C underwent total thyroidectomy plus CND. The latter were randomized to oral calcium (3 g/day) plus vitamin D (1 mcg/day) (group A, n = 49), calcium alone (group B, n = 49), or no supplements (group C, n = 50). Hypocalcemic symptoms, serum calcium, and parathyroid hormone (PTH) levels were compared among the groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| C | No intervention | –No supplements after total thyroidectomy and central neck dissection |
| D | No intervention | –No central neck dissection group (total thyroidectomy alone) |
| A | Active comparator | Dietary Supplement: Oral calcium plus vitamin DOral calcium plus vitamin D supplements after total thyroidectomy and central neck dissection |
| B | Active comparator | Dietary Supplement: Oral calcium aloneOral calcium alone supplement after total thyroidectomy and central neck dissection |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Differentiated papillary thyroid carcinoma
- Undergoing total thyroidectomy plus central neck dissection
Key exclusion criteria (4 listed)
- Previous thyroid or neck surgery
- Patients with parathyroid diseases
- Other thyroid malignancies
- Early loss of follow-up without proper evaluation of postoperative serum calcium levels and symptoms
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 |
|---|---|---|
| Oral calcium plus vitamin DAlso: calcium carbonate and one-alpha (vitamin D)calcium supplementation took 3 g/day oral calcium (1 g every 8 h) plus 1 mcg/day vitamin D (0.5 mcg every 12 h), beginning on the night of surgery and continuing for 14 days. | Dietary supplement | A |
| Oral calcium aloneAlso: calcium carbonate (Korea United Pharmaceutical Co, Seoul, Korea)calcium carbonate (3 g/day, 1 g every 8 h) | Dietary supplement | B |
Primary outcome
The clinical utility of calcium and vitamin D supplements for prevention of hypocalcemia following total thyroidectomy plus central neck dissection
Time frame: To postoperative 12 months
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 6 Mar 2008.
- Background: PubMed 12490862Bellantone R, Lombardi CP, Raffaelli M, Boscherini M, Alesina PF, De Crea C, Traini E, Princi P. Is routine supplementation therapy (calcium and vitamin D) useful after total thyroidectomy? Surgery. 2002 Dec;132(6):1109-12; discussion 1112-3. doi: 10.1067/msy.2002.128617.
- Results publication: PubMed 8156110Moore FD Jr. Oral calcium supplements to enhance early hospital discharge after bilateral surgical treatment of the thyroid gland or exploration of the parathyroid glands. J Am Coll Surg. 1994 Jan;178(1):11-6.
- Derived from this study: PubMed 19117033Roh JL, Park JY, Park CI. Prevention of postoperative hypocalcemia with routine oral calcium and vitamin D supplements in patients with differentiated papillary thyroid carcinoma undergoing total thyroidectomy plus central neck dissection. Cancer. 2009 Jan 15;115(2):251-8. doi: 10.1002/cncr.24027.
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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.
Jong-Lyel Roh, MD, PhD principal investigator
Asan Medical Center & Chungnam National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral calcium plus vitamin D and Oral calcium alone in people with Hypocalcemia, run by Asan Medical Center 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 2 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 6 Mar 2008. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The clinical utility of calcium and vitamin D supplements for prevention of hypocalcemia following total thyroidectomy plus central neck dissection (time frame: To postoperative 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00630214, which also lists 3 linked publications.
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 Mar 2008.