Actively Recruiting
Effects of Multiple Mega-dose of Vitamin D3 Supplementation on Ameliorating Moderate to Severe Chronic Pain in Hemodialysis Patients
Led by Taipei Medical University Hospital · Updated on 2023-03-30
120
Participants Needed
1
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Multiple Mega-dose of Vitamin D3 Supplementation on Ameliorating Moderate to Severe Chronic Pain in Hemodialysis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 years or older
- Currently receiving hemodialysis
- Parathyroid hormone (iPTH) level greater than 250 pg/mL
- Chronic pain with a Visual Analogue Scale (VAS) score of 4 or higher
- Willing to pay for two serum 25(OH)D level tests during the study
- Signed informed consent
You will not qualify if you...
- Participation in other clinical trials
- Chronic liver disease
- Diagnosis of sarcoidosis or multiple myeloma
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Taipei Medical University Hospital
Taipei, Taiwan, 110
Actively Recruiting
Research Team
H
Hsien-Tsung Lu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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