An interventional study of Vitamin D and Placebo in Hemodialysis, Chronic Pain and Hyperparathyroidism, sponsored by Taipei Medical University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-03-30.
Sponsored by Taipei Medical University Hospital · Not applicable, Interventional, and Treatment
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.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Taipei Medical University Hospital is the lead sponsor of 64 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral supplementaiton of 2,304,000 IU vitamin D3 in 4 weeks
Other: Vitamin D
Oral supplementaiton of placebo in 4 weeks
Other: Placebo
Oral supplementaiton of 576,000 IU once a week of vitamin D3 for 4 weeks
Oral supplementaiton of placebo once a week for 4 weeks
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)
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
Plan to share: No
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Taipei Medical University Hospital