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Trial record 40 of 97 for:    calcium cation

Routine Calcium for Preventing Hypocalcemia

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ClinicalTrials.gov Identifier: NCT03484416
Recruitment Status : Completed
First Posted : March 30, 2018
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Hyungju Kwon, Ewha Womans University Mokdong Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Thyroid Neoplasm Drug: Calcium Carbonate 1500 Mg with Vitamin D Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Routine Low-dose Calcium and Vitamin D Supplementation for Preventing Symptomatic Postthyroidectomy Hypocalcemia
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : May 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Routine calcium
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
Drug: Calcium Carbonate 1500 Mg with Vitamin D
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
Other Name: Dicamax 1000

No Intervention: control
Patients in the control group did not receive calcium or cholecalciferol for 2 weeks



Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with thyroid cancer
  • euthyroid state
  • underwent total thyroidectomy

Exclusion Criteria:

  • previous history of neck surgery or irradiation
  • calcium supplement before enrollment
  • hyperthyroidism or hypothyroidism
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484416


Locations
Korea, Republic of
Ewha Womans University Medical Center
Seoul, Korea, Republic of, 07985
Sponsors and Collaborators
Ewha Womans University Mokdong Hospital
Investigators
Principal Investigator: Hyungju Kwon, MD Ewah Womans University Medical Center

Responsible Party: Hyungju Kwon, Assistant Professor, Ewha Womans University Mokdong Hospital
ClinicalTrials.gov Identifier: NCT03484416     History of Changes
Other Study ID Numbers: Rouine Calcium
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Calcium Metabolism Disorders
Calcium, Dietary
Calcium Carbonate
Hypocalcemia
Thyroid Neoplasms
Metabolic Diseases
Water-Electrolyte Imbalance
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents