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

Primary Purpose

Hemodialysis, Chronic Pain, Hyperparathyroidism

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Vitamin D
Placebo
Sponsored by
Taipei Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemodialysis focused on measuring Vitamin D supplementation, Mega-dose vitamin D, Cholecalciferol, Chronic pain

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 Exclusion Criteria: Used to participate in other clinical trials Chronic liver disease Sarcoidosis or multiple myeloma

Sites / Locations

  • Taipei Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D group

Placebo Group

Arm Description

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

Oral supplementaiton of placebo in 4 weeks

Outcomes

Primary Outcome Measures

Visual Analogue Scale of Pain
Visual Analogue Scale of Pain
Visual Analogue Scale of Pain
Visual Analogue Scale of Pain
Visual Analogue Scale of Pain

Secondary Outcome Measures

25(OH)D level
Serum calcium
Serum phosphorus
C-reactive protein (CRP) test
Concentrations of parathyroid hormone (PTH)

Full Information

First Posted
December 18, 2022
Last Updated
March 29, 2023
Sponsor
Taipei Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05667090
Brief Title
Effects of Multiple Mega-dose of Vitamin D3 Supplementation on Ameliorating Moderate to Severe Chronic Pain in Hemodialysis Patients
Official Title
Effects of Multiple Mega-dose of Vitamin D3 Supplementation on Ameliorating Moderate to Severe Chronic Pain in Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis, Chronic Pain, Hyperparathyroidism
Keywords
Vitamin D supplementation, Mega-dose vitamin D, Cholecalciferol, Chronic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D group
Arm Type
Experimental
Arm Description
Oral supplementaiton of 2,304,000 IU vitamin D3 in 4 weeks
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Oral supplementaiton of placebo in 4 weeks
Intervention Type
Other
Intervention Name(s)
Vitamin D
Intervention Description
Oral supplementaiton of 576,000 IU once a week of vitamin D3 for 4 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral supplementaiton of placebo once a week for 4 weeks
Primary Outcome Measure Information:
Title
Visual Analogue Scale of Pain
Time Frame
Baseline (day 1)
Title
Visual Analogue Scale of Pain
Time Frame
week 2 (day 8)
Title
Visual Analogue Scale of Pain
Time Frame
week 3 (day 15)
Title
Visual Analogue Scale of Pain
Time Frame
week 4 (day 22)
Title
Visual Analogue Scale of Pain
Time Frame
week 5 (day 29)
Secondary Outcome Measure Information:
Title
25(OH)D level
Time Frame
Baseline (day 1) and week 5 (day 29) post-supplementation
Title
Serum calcium
Time Frame
Baseline (day 1) and week 5 (day 29) post-supplementation
Title
Serum phosphorus
Time Frame
Baseline (day 1) and week 5 (day 29) post-supplementation
Title
C-reactive protein (CRP) test
Time Frame
Baseline (day 1) and week 5 (day 29) post-supplementation
Title
Concentrations of parathyroid hormone (PTH)
Time Frame
Baseline (day 1) and week 5 (day 29) post-supplementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Exclusion Criteria: Used to participate in other clinical trials Chronic liver disease Sarcoidosis or multiple myeloma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsien-Tsung Lu, MD, PhD
Phone
+886 2-27372181
Ext
3740
Email
lu7788@tmu.edu.tw
Facility Information:
Facility Name
Taipei Medical University Hospital
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsien-Tsung Lu, MD, PhD
Phone
+886-27372181
Ext
3740
Email
lu7788@tmu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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