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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorTaipei Medical University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Used to participate in other clinical trials

Chronic liver disease

Sarcoidosis or multiple myeloma

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitamin D

    Other intervention

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

  • Placebo

    Other intervention

    Oral supplementaiton of placebo once a week for 4 weeks

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Vitamin D groupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Visual Analogue Scale of Pain

Time frame
Baseline (day 1)
2

Visual Analogue Scale of Pain

Time frame
week 2 (day 8)
3

Visual Analogue Scale of Pain

Time frame
week 3 (day 15)
4

Visual Analogue Scale of Pain

Time frame
week 4 (day 22)

Secondary outcomes

1

25(OH)D level

Time frame
Baseline (day 1) and week 5 (day 29) post-supplementation
2

Serum calcium

Time frame
Baseline (day 1) and week 5 (day 29) post-supplementation
3

Serum phosphorus

Time frame
Baseline (day 1) and week 5 (day 29) post-supplementation
4

C-reactive protein (CRP) test

Time frame
Baseline (day 1) and week 5 (day 29) post-supplementation

Other outcomes

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