Randomized controlled trial2018Open access

Cholecalciferol Additively Reduces Serum Parathyroid Hormone Levels in Severe Secondary Hyperparathyroidism Treated with Calcitriol and Cinacalcet among Hemodialysis Patients

Zheng CM, Wu CC, Hung CF, Liao MT, Shyu JF, Hsu YH, Lu CL, Wang YH, Zheng JQ, Chang TJ, Lin YF, Lu KC

Nutrients · 15 citations

How it was studied

Design
Randomized controlled trial (indexed by PubMed)
Studied in
People
Main outcome
Health markers and function

Who paid for it

Funding
Independent funding

Based on full-text disclosure statement.

Publication

Published
2018-02-10 · Nutrients · vol. 10 · issue 2 · p. 196
Publisher
Multidisciplinary Digital Publishing Institute
Cited
19 citations · more than 82% of similar papers · 1.8× the field average
References
52 works
Access
Open access (journal) · CC-BY
Research areas
Parathyroid Disorders and Treatments · Vitamin D Research Studies · Pharmacological Effects and Toxicity Studies
Keywords
Cinacalcet, Calcitriol, Cholecalciferol, Secondary hyperparathyroidism, Medicine, Calcimimetic, Endocrinology, Internal medicine, Vitamin D and neurology, Hyperparathyroidism, Parathyroid hormone, Hemodialysis, Placebo, Urology, Calcium
MeSH
femur neck, humans, hyperparathyroidism, secondary, cholecalciferol, calcifediol, calcitriol, parathyroid hormone, vitamins, renal dialysis, severity of illness index, bone density, dietary supplements, aged, middle aged, female, male, calcimimetic agents, cinacalcet

12 authors

From TW

  • Cai‐Mei ZhengTaipei Medical University-Shuang Ho Hospital; Taipei Medical University
  • Chia‐Chao WuTri-Service General Hospital; National Defense Medical Center
  • Chi‐Feng HungFu Jen Catholic University
  • Min-Tser LiaoTri-Service General Hospital; Taoyuan Armed Forces General Hospital; National Defense Medical Center
  • Jia‐Fwu ShyuNational Defense Medical Center
  • Yung-Ho HsuTaipei Medical University-Shuang Ho Hospital; Taipei Medical University

Abstract

We evaluated the improvement of intact parathyroid hormone (iPTH) levels and bone parameters by supplementing nutritional vitamin D (cholecalciferol) to combined calcimimetic (cinacalcet) and active vitamin D analog (calcitriol) among severe secondary hyperparathyroidism (SHPT) hemodialysis (HD) patients. A randomized, controlled open-label study was undertaken in 60 HD patients with serum iPTH > 1000 pg/mL or persistently high iPTH ≥ 600 pg/mL even after >3 months of calcitriol (3 μg/week). The study group received oral cholecalciferol (5000 IU/ day) and the control group received a placebo. All patients received fixed dose cinacalcet (30 mg/day, orally) and calcitriol. Calcitriol was reduced if iPTH ≤ 300 pg/mL and cinacalcet was withdrawn if serum iPTH was persistently low (iPTH ≤ 300 pg/mL) for 4 weeks after the reduction of calcitriol. A significantly lower iPTH level was noted from the 20th week in the study group compared to the placebo group, and the target iPTH ≤ 300 pg/mL was achieved at the 24th week in the study group. Most patients achieved serum 25-(OH)D₃ ≥ 30 ng/mL in the study group. Nearly 40% of study patients gained >10% improvement in femoral neck (FN) bone mineral density (BMD). We conclude that cholecalciferol additively reduced serum iPTH levels, improved 25-(OH)D₃ levels and improved FN BMD when used together with cinacalcet/calcitriol in severe SHPT HD patients.

Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).

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