NCT05667090

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Taipei Medical University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemodialysis
• Chronic Pain
• Hyperparathyroidism

Interventions

Type	Name	Description
OTHER	Vitamin D	Oral supplementaiton of 576,000 IU once a week of vitamin D3 for 4 weeks
OTHER	Placebo	Oral supplementaiton of placebo once a week for 4 weeks

Timeline

• Start date: 2023-03-15
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2022-12-28
• Last updated: 2023-03-30

Locations

1 site across 1 country: Taiwan