Clinical Trial

Effects of Multiple Mega-dose of Vitamin D3 Supplementation on Ameliorating Moderate to Severe Chronic Pain in Hemodialysis Patients

Recruiting
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Record status
This record was last updated March 30, 2023 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
Pain is a major complaint in hemodialysis (HD) patients. Concentrations of parathyroid hormone (PTH) \>250 pg/ml are associated with chronic pain. Visual Analogue Scale (VAS) score which is used to assess the pain severity is positively related to PTH levels. This study is aimed to assess the effects of multiple mega dosages vitamin D supplementations in HD patients with chronic pain. It's a single-center, parallel, double-blind randomized control trial that administrations of 576,000 IU once a week of vitamin D3 for 4 weeks or placebo are for 120 eligible subjects. VAS and laboratory tests including serum concentrations of 25(OH)D, calcium, phosphorus, PTH and C-reactive protein will be evaluated.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2022-12-26.
Status change: Not Yet Recruiting → Recruiting 2023-03-29
Trial Details
NCT Number NCT05667090
Lead Sponsor Taipei Medical University Hospital
Conditions Hemodialysis, Chronic Pain, Hyperparathyroidism
Enrollment 120 participants
Start Date 2023-03-15
Primary Completion 2025-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2023-03-30