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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

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

Secondary Outcome Measures

25(OH)D level

Serum calcium

Serum phosphorus

C-reactive protein (CRP) test

Concentrations of parathyroid hormone (PTH)

Full Information

NCT ID

NCT05667090

First Posted

December 18, 2022

Last Updated

March 29, 2023

Sponsor

Taipei Medical University Hospital

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

Studies a U.S. FDA-regulated Device Product

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