NCT05667090

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Mar 2023Dec 2027

First Submitted

Initial submission to the registry

December 18, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 28, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

March 30, 2023

Status Verified

December 1, 2022

Enrollment Period

2.8 years

First QC Date

December 18, 2022

Last Update Submit

March 29, 2023

Conditions

HemodialysisChronic PainHyperparathyroidism

Keywords

Vitamin D supplementationMega-dose vitamin DCholecalciferolChronic pain

Outcome Measures

Primary Outcomes (5)

  • Visual Analogue Scale of Pain

    Baseline (day 1)

  • Visual Analogue Scale of Pain

    week 2 (day 8)

  • Visual Analogue Scale of Pain

    week 3 (day 15)

  • Visual Analogue Scale of Pain

    week 4 (day 22)

  • Visual Analogue Scale of Pain

    week 5 (day 29)

Secondary Outcomes (5)

  • 25(OH)D level

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

  • Serum calcium

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

  • Serum phosphorus

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

  • C-reactive protein (CRP) test

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

  • Concentrations of parathyroid hormone (PTH)

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

Study Arms (2)

Vitamin D group

EXPERIMENTAL

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

Other: Vitamin D

Placebo Group

PLACEBO COMPARATOR

Oral supplementaiton of placebo in 4 weeks

Other: Placebo

Interventions

Vitamin DOTHER

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

Vitamin D group
PlaceboOTHER

Oral supplementaiton of placebo once a week for 4 weeks

Placebo Group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Used to participate in other clinical trials
  • Chronic liver disease
  • Sarcoidosis or multiple myeloma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

MeSH Terms

Conditions

Chronic PainHyperparathyroidism

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsParathyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Hsien-Tsung Lu, MD, PhD

CONTACT

+886 2-27372181lu7788@tmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2022

First Posted

December 28, 2022

Study Start

March 15, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

March 30, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)