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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of high-dose vitamin D3 supplementation on moderate to severe chronic pain in patients undergoing hemodialysis who have elevated parathyroid hormone levels. This study is designed as a single-center, parallel, double-blind randomized controlled trial involving 120 eligible adults. The goal is to see if multiple mega doses of vitamin D3 can help reduce chronic pain measured by the Visual Analogue Scale (VAS). Participants will be randomly assigned to receive either oral vitamin D3 supplementation at a dose of 576,000 IU once a week for four weeks, totaling 2,304,000 IU, or a placebo given on the same schedule. The study lasts for four weeks of treatment, with the vitamin D3 or placebo taken weekly. During the trial, participants will have their pain severity assessed at baseline and weekly for five weeks using the VAS. Blood tests will measure serum levels of 25(OH)D, calcium, phosphorus, parathyroid hormone (PTH), and C-reactive protein at the start and after supplementation. Researchers will monitor these measures to evaluate the supplementation's impact on pain and related biochemical markers throughout the study period.
CONDITIONS
Brief 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...
- Hemodialysis patient aged 20 years or older
- Parathyroid hormone (iPTH) level above 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
- Able to provide informed consent
You will not qualify if you...
- Previous participation in other clinical trials
- Chronic liver disease
- Diagnosis of sarcoidosis or multiple myeloma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 weeks
Participants receive weekly oral supplementation of either mega-dose vitamin D3 or placebo for 4 weeks.
4 weekly visits (in-person)
Duration - 1 week
Participants are monitored for outcomes and safety after completing supplementation.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Taipei Medical University Hospital
Taipei, Taiwan, 110
Actively Recruiting
Research Team
H
Hsien-Tsung Lu, MD, PhD
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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