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

Taipei Medical University

Status: Enrolling

Conditions: Hemodialysis; Hyperparathyroidism; Chronic Pain

Treatments: Other: Vitamin D; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05667090

N202209072

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Vitamin D group

Experimental group

Description:

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

Treatment:

Other: Vitamin D

Placebo Group

Placebo Comparator group

Description:

Oral supplementaiton of placebo in 4 weeks

Treatment:

Other: Placebo