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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Taiwan
Taipei Medical University Hospital
RECRUITING
Taipei
Contact Information
Primary
Hsien-Tsung Lu, MD, PhD
lu7788@tmu.edu.tw
+886 2-27372181
Time Frame
Start Date: 2023-03-15
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 120
Treatments
Experimental: Vitamin D group
Oral supplementaiton of 2,304,000 IU vitamin D3 in 4 weeks
Placebo_comparator: Placebo Group
Oral supplementaiton of placebo in 4 weeks
Related Therapeutic Areas
Sponsors
Leads: Taipei Medical University Hospital

This content was sourced from clinicaltrials.gov