Chronic Pain, Hemodialysis, Hyperparathyroidism
Conditions
Keywords
Vitamin D supplementation, Mega-dose vitamin D, Cholecalciferol, Chronic pain
Brief 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.
Interventions
OTHERVitamin D
Oral supplementaiton of 576,000 IU once a week of vitamin D3 for 4 weeks
OTHERPlacebo
Oral supplementaiton of placebo once a week for 4 weeks
Sponsors
Taipei Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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 the study 5. Sign the informed consent
Exclusion criteria
1. Used to participate in other clinical trials 2. Chronic liver disease 3. Sarcoidosis or multiple myeloma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale of Pain | Baseline (day 1) |
Secondary
| Measure | Time frame |
|---|---|
| 25(OH)D level | Baseline (day 1) and week 5 (day 29) post-supplementation |
| Serum calcium | Baseline (day 1) and week 5 (day 29) post-supplementation |
| Serum phosphorus | Baseline (day 1) and week 5 (day 29) post-supplementation |
| C-reactive protein (CRP) test | Baseline (day 1) and week 5 (day 29) post-supplementation |
| Concentrations of parathyroid hormone (PTH) | Baseline (day 1) and week 5 (day 29) post-supplementation |
Countries
Taiwan
Contacts
Primary ContactHsien-Tsung Lu, MD, PhD
Outcome results
None listed