Effects of Multiple Mega-dose of Vitamin D3 Supplementation on Ameliorating Moderate to Severe Chronic Pain in Hemodialysis Patients
Taipei Medical University Hospital
120 participants
Mar 15, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- Haemodialysis subject ≥ 20 years old
- iPTH > 250 pg/mL
- Chronic pain with visual analogue scale (VAS) score ≥ 4
- Voluntary to check serum 25(OH)D levels two times by his/her own payment during the study
- Sign the informed consent
Exclusion Criteria3
- Used to participate in other clinical trials
- Chronic liver disease
- Sarcoidosis or multiple myeloma
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Interventions
Oral supplementaiton of 576,000 IU once a week of vitamin D3 for 4 weeks
Oral supplementaiton of placebo once a week for 4 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05667090