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Not Yet Recruiting NCT05667090

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

Conditions: Hemodialysis, Chronic Pain, Hyperparathyroidism

Sex: All
Ages: 20 Years – N/A
Phase: NA
Enrollment: 120
Sponsor: Taipei Medical University Hospital

Location: Taiwan

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:Haemodialysis subject ≥ 20 years oldiPTH > 250 pg/mLChronic pain with visual analogue scale (VAS) score ≥ 4Voluntary to check serum 25(OH)D levels two times by his/her own payment during the studySign the informed consentExclusion Criteria:Used to participate in other clinical trialsChronic liver diseaseSarcoidosis or multiple myeloma

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05667090). StuddyBuddy aggregates publicly available trial information.