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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05667090
• Other study ID #: N202209072
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: December 2022
• Source: Taipei Medical University Hospital
• Contact: Hsien-Tsung Lu, MD, PhD
• Phone: +886 2-27372181
• Email: lu7788[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Hemodialysis
• Hyperparathyroidism

Intervention

Other:
• Vitamin D
Oral supplementaiton of 576,000 IU once a week of vitamin D3 for 4 weeks
• Placebo
Oral supplementaiton of placebo once a week for 4 weeks

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale of Pain		Baseline (day 1)
Primary	Visual Analogue Scale of Pain		week 2 (day 8)
Primary	Visual Analogue Scale of Pain		week 3 (day 15)
Primary	Visual Analogue Scale of Pain		week 4 (day 22)
Primary	Visual Analogue Scale of Pain		week 5 (day 29)
Secondary	25(OH)D level		Baseline (day 1) and week 5 (day 29) post-supplementation
Secondary	Serum calcium		Baseline (day 1) and week 5 (day 29) post-supplementation
Secondary	Serum phosphorus		Baseline (day 1) and week 5 (day 29) post-supplementation
Secondary	C-reactive protein (CRP) test		Baseline (day 1) and week 5 (day 29) post-supplementation
Secondary	Concentrations of parathyroid hormone (PTH)		Baseline (day 1) and week 5 (day 29) post-supplementation