Vitamin D3 supplementation for chronic pain relief in hemodialysis patients
Effects of Multiple Mega-dose of Vitamin D3 Supplementation on Ameliorating Moderate to Severe Chronic Pain in Hemodialysis Patients
This study is testing if high doses of vitamin D3 can help reduce chronic pain in patients on hemodialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Taipei Medical University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT05667090 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of high-dose vitamin D3 supplementation on chronic pain in patients undergoing hemodialysis. It is a single-center, double-blind, randomized control trial involving 120 participants who will receive either 576,000 IU of vitamin D3 weekly for four weeks or a placebo. The study will assess pain severity using the Visual Analogue Scale (VAS) and measure various laboratory parameters, including parathyroid hormone levels and vitamin D status. The goal is to determine if vitamin D3 can alleviate chronic pain associated with elevated parathyroid hormone levels in this patient population.
Who should consider this trial
Good fit: Ideal candidates are hemodialysis patients aged 20 and older with chronic pain and elevated parathyroid hormone levels.
Not a fit: Patients with chronic liver disease, sarcoidosis, or those participating in other clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce chronic pain in hemodialysis patients, improving their quality of life.
How similar studies have performed: While there is limited research specifically on mega-dose vitamin D for chronic pain in hemodialysis patients, vitamin D supplementation has shown promise in other chronic pain conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Haemodialysis subject ≥ 20 years old 2. iPTH \> 250 pg/mL 3. Chronic pain with visual analogue scale (VAS) score ≥ 4 4. Voluntary to check serum 25(OH)D levels two times by his/her own payment during the study 5. Sign the informed consent Exclusion Criteria: 1. Used to participate in other clinical trials 2. Chronic liver disease 3. Sarcoidosis or multiple myeloma
Where this trial is running
Taipei
- Taipei Medical University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Hsien-Tsung Lu, MD, PhD
- Email: lu7788@tmu.edu.tw
- Phone: +886 2-27372181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.