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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Oral supplementaiton of 576,000 IU once a week of vitamin D3 for 4 weeks
Oral supplementaiton of placebo once a week for 4 weeks
Taipei Medical University Hospital
Taipei, Taiwan
RECRUITINGVisual Analogue Scale of Pain
Time frame: Baseline (day 1)
Visual Analogue Scale of Pain
Time frame: week 2 (day 8)
Visual Analogue Scale of Pain
Time frame: week 3 (day 15)
Visual Analogue Scale of Pain
Time frame: week 4 (day 22)
Visual Analogue Scale of Pain
Time frame: week 5 (day 29)
25(OH)D level
Time frame: Baseline (day 1) and week 5 (day 29) post-supplementation
Serum calcium
Time frame: Baseline (day 1) and week 5 (day 29) post-supplementation
Serum phosphorus
Time frame: Baseline (day 1) and week 5 (day 29) post-supplementation
C-reactive protein (CRP) test
Time frame: Baseline (day 1) and week 5 (day 29) post-supplementation
Concentrations of parathyroid hormone (PTH)
Time frame: Baseline (day 1) and week 5 (day 29) post-supplementation
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