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Effects of Multiple Mega-dose of Vitamin D3 Supplementation on Ameliorating Moderate to Severe Chronic Pain in Hemodialysis Patients

RecruitingNAAges 20 Years - anyAllTaipei Medical University Hospital
NCT05667090 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Vitamin D
  • Placebo
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Where

1 site
Taipei Medical University Hospital
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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