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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Hemodialysis, Chronic Pain, Hyperparathyroidism

In brief

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.

Key facts

Study ID

NCT05667090

Run by

Taipei Medical University Hospital

People needed

120

Starts

2023-03-15

Expected to finish

2027-12-31

Last updated by the study team

2023-03-30

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Used to participate in other clinical trials
• Chronic liver disease
• Sarcoidosis or multiple myeloma

Where it is running

• Taipei Medical University Hospital — Taipei, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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