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

Not Applicable

Recruiting

• Conditions: Hyperparathyroidism; Chronic Pain; Hemodialysis
• Interventions: Other: Vitamin D; Other: Placebo

• Registration Number: NCT05667090
• Lead Sponsor: Taipei Medical University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-18
• Study First Submitted QC: 2022-12-26
• Study First Posted: 2022-12-28
• Study Start: 2023-03-15
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-30
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D group	Vitamin D	Oral supplementaiton of 2,304,000 IU vitamin D3 in 4 weeks
Placebo Group	Placebo	Oral supplementaiton of placebo in 4 weeks

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale of Pain	week 5 (day 29)

Secondary Outcome Measures

Name	Time	Method
Serum phosphorus	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
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
C-reactive protein (CRP) test	Baseline (day 1) and week 5 (day 29) post-supplementation

Trial Locations

Locations (1)

Taipei Medical University Hospital; 🇨🇳 Taipei, Taiwan