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

Last updated: March 29, 2023
Sponsor: Taipei Medical University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Hemodialysis

Hyperparathyroidism

Treatment

N/A

Clinical Study ID

NCT05667090
N202209072
  • Ages > 20
  • All Genders

Study 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

Inclusion Criteria:

  1. Haemodialysis subject ≥ 20 years old
  2. iPTH > 250 pg/mL
  3. Chronic pain with visual analogue scale (VAS) score ≥ 4
  4. Voluntary to check serum 25(OH)D levels two times by his/her own payment during thestudy
  5. Sign the informed consent

Exclusion

Exclusion Criteria:

  1. Used to participate in other clinical trials
  2. Chronic liver disease
  3. Sarcoidosis or multiple myeloma

Study Design

Total Participants: 120
Study Start date:
March 15, 2023
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Taipei Medical University Hospital

    Taipei, 110
    Taiwan

    Active - Recruiting

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