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临床试验/NCT00982722
NCT00982722已完成不适用

Vitamin D Supplementation After Successful Parathyroid Surgery for Primary Hyperparathyroidism

Karolinska University Hospital2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
2
主要终点
postoperative parathyroid hormone level

研究概览

简要总结

A randomised double blind clinical trial, accepted by the Medical Products Agency and registered in the European Clinical Trials Database. Aims to evaluate the prevalence of vitamin D deficiency in a pHPT population in relation to gender and age, the correlation between vitamin D status, pre- and postoperative parathyroid hormone level and bone density and the correlation between vitamin D status, metabolic, cardiovascular risk factors and QoL aspects before and after parathyroid adenomectomy.

详细描述

150 PHPT patients were randomized six weeks after surgery, 75 into each group, to 1 year of oral treatment with either calcium carbonate 1 g (500 mg twice daily) alone or calcium carbonate 1 g combined with cholecalciferol 1600 IU (800 IU twice daily). Exclusion criteria were age under 18, manifest osteoporosis at PHPTdiagnosis, persistent hypercalcemia after surgery, postoperative hypocalcemia requiring vitamin D treatment, glomerular filtration rate (GFR) below 40 ml/min, pregnancy, breast feeding, or logistical difficulties, for example living far from the hospital. Included patients had to withdraw any current supplementation with calcium and vitamin D during the study period. All tablets were identical in appearance, the tins were numbered and randomization followed a list compiled by an independent clinical research support organization. The time for randomization was chosen to make sure that the PHPT patients were cured before starting the study medication. Nearly three-quarters of the patients were randomized within 6 weeks after PTX.The primary end point was the change in PTH after PTX and treatment with the study medication. Secondary end points were vitamin D levels, insulin resistance, blood pressure and other cardiovascular risk factors, biochemical markers of bone turnover, bone mineral density and self estimated health related quality of life (SF- 36).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Primary hyperparathyroidism subjected to parathyroid surgery

排除标准

  • Renal insufficiency
  • Severe osteoporosis
  • Pregnancy

研究组 & 干预措施

cholecalciferol and calcium carbonate

Experimental

cholecalciferol 800 IUx2 and calcium carbonate 500 mg x 2

干预措施: calcium carbonate (Drug)

calciumcarbonate

Active Comparator

calcium carbonate 500 mg x 2

干预措施: cholecalciferol and calcium carbonate (Drug)

结局指标

主要结局

postoperative parathyroid hormone level

时间窗: 3 months

PTH

ambulatory blood pressure

时间窗: one year

24h blood pressure

次要结局

  • bone mineral density(one year)
  • Calcium(6 weeks)
  • Quality of life-self estimating formularies(one year)
  • 25-OH Vitamin D(3 months)

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Inga-Lena Nilsson

Assoc prof, senior consultant

Karolinska University Hospital

研究点 (2)

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