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OpenTrials
Completed

NCT Number: NCT00630214

Prevention of Hypocalcemia in Patients Undergoing Total Thyroidectomy Plus Central Neck Dissection

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.

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Key information

Conditions

Hypocalcemia Calcium Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

15 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chungnam National University Hospital

Daejeon, 301-040, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Differentiated papillary thyroid carcinoma
  • Undergoing total thyroidectomy plus central neck dissection

Exclusion criteria

  • 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

Treatment and study plan

Oral calcium plus vitamin D

Dietary Supplement

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.

Other names: calcium carbonate and one-alpha (vitamin D)

Oral calcium alone

Dietary Supplement

calcium carbonate (3 g/day, 1 g every 8 h)

Other names: calcium carbonate (Korea United Pharmaceutical Co, Seoul, Korea)

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Chungnam National University

Registry information

Official study title

Phase 2 Study of Routine Oral Calcium and Vitamine D Supplements to Prevent Hypocalcemia After Total Thyroidectomy in Papillary Thyroid Carcinoma Patients

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Mar 6, 2008
Registry last updated
Mar 6, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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