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Recruiting NCT05667090

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

No phase Interventional Hemodialysis Chronic Pain Hyperparathyroidism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vitamin D, Placebo.
Who it may be relevant to
Registry conditions: Hemodialysis, Chronic Pain, Hyperparathyroidism. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Visual Analogue Scale of Pain [Time frame: Baseline (day 1)]
  • Visual Analogue Scale of Pain [Time frame: week 2 (day 8)]
  • Visual Analogue Scale of Pain [Time frame: week 3 (day 15)]
  • Visual Analogue Scale of Pain [Time frame: week 4 (day 22)]
  • Visual Analogue Scale of Pain [Time frame: week 5 (day 29)]
Secondary outcome measures (5)
  • 25(OH)D level [Time frame: Baseline (day 1) and week 5 (day 29) post-supplementation]
  • Serum calcium [Time frame: Baseline (day 1) and week 5 (day 29) post-supplementation]
  • Serum phosphorus [Time frame: Baseline (day 1) and week 5 (day 29) post-supplementation]
  • C-reactive protein (CRP) test [Time frame: Baseline (day 1) and week 5 (day 29) post-supplementation]
  • Concentrations of parathyroid hormone (PTH) [Time frame: Baseline (day 1) and week 5 (day 29) post-supplementation]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Taipei Medical University Hospital — Taipei

Identifiers

NCT: NCT05667090 · N202209072

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗