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NCT Number: NCT05667090

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

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.

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Key information

Conditions

Hemodialysis Chronic Pain Endocrine System Diseases Hyperparathyroidism Neurologic Manifestations Pain Parathyroid Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location status: Recruiting

Location contact

Hsien-Tsung Lu, MD, PhD

CONTACT

[email protected]

+886-27372181 ext. 3740

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Other

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

Placebo

Other

Oral supplementaiton of placebo once a week for 4 weeks

Primary outcomes

  1. Visual Analogue Scale of Pain

    Time frame: Baseline (day 1)

  2. Visual Analogue Scale of Pain

    Time frame: week 2 (day 8)

  3. Visual Analogue Scale of Pain

    Time frame: week 3 (day 15)

  4. Visual Analogue Scale of Pain

    Time frame: week 4 (day 22)

  5. Visual Analogue Scale of Pain

    Time frame: week 5 (day 29)

Secondary outcomes

  1. 25(OH)D level

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

  2. Serum calcium

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

  3. Serum phosphorus

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

  4. C-reactive protein (CRP) test

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

  5. Concentrations of parathyroid hormone (PTH)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Hsien-Tsung Lu, MD, PhD

CONTACT

[email protected]

+886 2-27372181 ext. 3740

Sponsors and collaborators

Lead sponsor

Taipei Medical University Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Dec 28, 2022
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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