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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hemodialysis, Chronic Pain, Hyperparathyroidism

Intervention / Treatment
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* Other: Vitamin D
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D group<br>Oral supplementaiton of 2,304,000 IU vitamin D3 in 4 weeks | Other: Vitamin D<br>* Oral supplementaiton of 576,000 IU once a week of vitamin D3 for 4 weeks<br>|
| Placebo Comparator: Placebo Group<br>Oral supplementaiton of placebo in 4 weeks | Other: Placebo<br>* Oral supplementaiton of placebo once a week for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale of Pain |  | Baseline (day 1) | 
| Visual Analogue Scale of Pain |  | week 2 (day 8) | 
| Visual Analogue Scale of Pain |  | week 3 (day 15) | 
| Visual Analogue Scale of Pain |  | week 4 (day 22) | 
| Visual Analogue Scale of Pain |  | week 5 (day 29) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D supplementation, Mega-dose vitamin D, Cholecalciferol, Chronic pain