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

NCT ID: NCT05667090

Last Updated: 2023-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Hemodialysis Chronic Pain Hyperparathyroidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D group

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

Group Type EXPERIMENTAL

Vitamin D

Intervention Type OTHER

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

Placebo Group

Oral supplementaiton of placebo in 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Oral supplementaiton of placebo once a week for 4 weeks

Interventions

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Vitamin D

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

Intervention Type OTHER

Placebo

Oral supplementaiton of placebo once a week for 4 weeks

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taipei Medical University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hsien-Tsung Lu, MD, PhD

Role: CONTACT

+886 2-27372181 ext. 3740

Facility Contacts

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Hsien-Tsung Lu, MD, PhD

Role: primary

+886-27372181 ext. 3740

Other Identifiers

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N202209072

Identifier Type: -

Identifier Source: org_study_id

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