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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D group | Experimental | Oral supplementaiton of 2,304,000 IU vitamin D3 in 4 weeks |
|
| Placebo Group | Placebo Comparator | Oral supplementaiton of placebo in 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Other | Oral supplementaiton of 576,000 IU once a week of vitamin D3 for 4 weeks |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hsien-Tsung Lu, MD, PhD | Contact | +886 2-27372181 | 3740 | lu7788@tmu.edu.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Hospital | Recruiting | Taipei | 110 | Taiwan |
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| Placebo | Other | Oral supplementaiton of placebo once a week for 4 weeks |
|
| 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 |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D006961 | Hyperparathyroidism |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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