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

Sponsor

Taipei Medical University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05667090

Collaborator

(none)

120

Enrollment

Location

Arms

59.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemodialysis Chronic Pain Hyperparathyroidism	Other: Vitamin D Other: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 4, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Vitamin D group

Oral supplementaiton of 2,304,000 IU vitamin D3 in 4 weeks

Other: Vitamin D

Oral supplementaiton of 576,000 IU once a week of vitamin D3 for 4 weeks

Placebo Comparator: Placebo Group

Oral supplementaiton of placebo in 4 weeks

Other: Placebo

Oral supplementaiton of placebo once a week for 4 weeks

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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