HemodialysisNCT05667090
Effects of Multiple Mega-dose of Vitamin D3 Supplementation on Ameliorating Moderate to Severe Chronic Pain in Hemodialysis Patients
A study testing Vitamin D in people with Hemodialysis and Chronic Pain, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hemodialysis, Chronic Pain, Hyperparathyroidism
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Mar 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Used to participate in other clinical trials
- Chronic liver disease
- Sarcoidosis or multiple myeloma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Hospital
Taipei, 110
Hsien-Tsung Lu, MD, PhD, +886-27372181 ext. 3740, lu7788@tmu.edu.tw
About this study
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.
- Conditions
- Hemodialysis, Chronic Pain, Hyperparathyroidism
- Being tested
- Vitamin D, Placebo
- Keywords
- Vitamin D supplementation, Mega-dose vitamin D, Cholecalciferol, Chronic pain
- Medical subject headings
- Chronic Pain, Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DOther
Oral supplementaiton of 576,000 IU once a week of vitamin D3 for 4 weeks
PlaceboOther
Oral supplementaiton of placebo once a week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D group | Experimental | Oral supplementaiton of 2,304,000 IU vitamin D3 in 4 weeks Receives: Other: Vitamin D |
| Placebo Group | Placebo comparator | Oral supplementaiton of placebo in 4 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale of Pain
Measured: Baseline (day 1)
Visual Analogue Scale of Pain
Measured: week 2 (day 8)
Visual Analogue Scale of Pain
Measured: week 3 (day 15)
Visual Analogue Scale of Pain
Measured: week 4 (day 22)
Visual Analogue Scale of Pain
Measured: week 5 (day 29)
Secondary outcomes (5)
25(OH)D level
Measured: Baseline (day 1) and week 5 (day 29) post-supplementation
Serum calcium
Measured: Baseline (day 1) and week 5 (day 29) post-supplementation
Serum phosphorus
Measured: Baseline (day 1) and week 5 (day 29) post-supplementation
C-reactive protein (CRP) test
Measured: Baseline (day 1) and week 5 (day 29) post-supplementation
Concentrations of parathyroid hormone (PTH)
Measured: Baseline (day 1) and week 5 (day 29) post-supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start15 Mar 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667090
- Sponsor's protocol ID
- N202209072
- Status last verified
- Dec 2022
- First submitted
- 18 Dec 2022
- Last updated
- 30 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multiple Mega-dose of Vitamin D3 Supplementation on Ameliorating Moderate to Severe Chronic Pain in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05667090
- Acronym / sponsor ID
- N202209072
- Conditions
- Hemodialysis, Chronic Pain, Hyperparathyroidism
- Keywords
- Vitamin D supplementation, Mega-dose vitamin D, Cholecalciferol, Chronic pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D group | Experimental | Other: Vitamin DOral supplementaiton of 2,304,000 IU vitamin D3 in 4 weeks |
| Placebo Group | Placebo comparator | Other: PlaceboOral supplementaiton of placebo in 4 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Used to participate in other clinical trials
- Chronic liver disease
- Sarcoidosis or multiple myeloma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DOral supplementaiton of 576,000 IU once a week of vitamin D3 for 4 weeks | Other | Vitamin D group |
| PlaceboOral supplementaiton of placebo once a week for 4 weeks | Other | Placebo Group |
Primary outcome
Visual Analogue Scale of Pain
Time frame: Baseline (day 1)
Visual Analogue Scale of Pain
Time frame: week 2 (day 8)
Visual Analogue Scale of Pain
Time frame: week 3 (day 15)
Visual Analogue Scale of Pain
Time frame: week 4 (day 22)
Visual Analogue Scale of Pain
Time frame: week 5 (day 29)
5 secondary outcomes
25(OH)D level
Time frame: Baseline (day 1) and week 5 (day 29) post-supplementation
Serum calcium
Time frame: Baseline (day 1) and week 5 (day 29) post-supplementation
Serum phosphorus
Time frame: Baseline (day 1) and week 5 (day 29) post-supplementation
C-reactive protein (CRP) test
Time frame: Baseline (day 1) and week 5 (day 29) post-supplementation
Concentrations of parathyroid hormone (PTH)
Time frame: Baseline (day 1) and week 5 (day 29) post-supplementation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Hemodialysis
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Hemodialysis and Chronic Pain, run by Taipei Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsien-Tsung Lu, MD, PhD (+886 2-27372181 ext. 3740, lu7788@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale of Pain (time frame: Baseline (day 1)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.