NCT05667090 Effects of Multiple Mega-dose of Vitamin D3 Supplementation on Ameliorating Moderate to Severe Chronic Pain in Hemodialysis Patients
| NCT ID | NCT05667090 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Taipei Medical University Hospital |
| Condition | Hemodialysis |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-03-15 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2023-03-15 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05667090 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Hemodialysis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05667090 currently recruiting?
Yes, NCT05667090 is actively recruiting participants. Contact the research team at lu7788@tmu.edu.tw for enrollment information.
Where is the NCT05667090 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT05667090 clinical trial?
NCT05667090 is sponsored by Taipei Medical University Hospital. The trial plans to enroll 120 participants.