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Vitamin D Supplements for Neuropathic Pain
Phase 2
Recruiting
Led By Susan Hong, MD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial is testing whether giving vitamin D supplements to people with Vitamin D deficiency who are about to start taxane-based chemotherapy can improve their health outcomes.
Who is the study for?
This trial is for individuals with Vitamin D deficiency who are about to start taxane-based chemotherapy at VCU Health Massey Cancer Center. They must have stage I-III cancer or stage IV treated with curative intent, and a Vitamin D level below 20 ng/mL. Excluded are those with pre-existing neuropathy, non-English speakers, certain chronic diseases, hypercalcemia, prior taxane chemotherapy, current prescription Vitamin D use, or pregnancy.Check my eligibility
What is being tested?
The study compares two groups: one receiving prescribed vitamin D supplements (either Ergocalciferol or Cholecalciferol capsules) and the other receiving standard care without supplementation. The goal is to see if vitamin D can reduce nerve pain caused by taxane chemotherapy in patients deficient in this nutrient.See study design
What are the potential side effects?
Potential side effects from taking high doses of vitamin D may include nausea, vomiting, loss of appetite, constipation, weakness and an increase in blood calcium levels which could lead to confusion or heart rhythm abnormalities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Self-reported neuropathic pain- autonomic symptoms
Self-reported neuropathic pain- motor symptoms
Neuralgia
Secondary outcome measures
Clinical diagnosis of peripheral neuropathy
Self-reported neuropathic pain
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Vitamin D ReplacementExperimental Treatment1 Intervention
Participants will receive prescribed oral vitamin D2 to achieve a serum vitamin D level between 30 ng/mL to 50 ng/mL.
Group II: Observation ArmActive Control1 Intervention
Observation only
Group III: Standard of CareActive Control1 Intervention
Participants will receive standard-of-care advice to take over the counter vitamin D.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ergocalciferol Capsules
2022
Completed Phase 4
~70
Find a Location
Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
699 Previous Clinical Trials
22,884,925 Total Patients Enrolled
3 Trials studying Neuropathic Pain
265 Patients Enrolled for Neuropathic Pain
Susan Hong, MDPrincipal InvestigatorVirginia Commonwealth University
2 Previous Clinical Trials
125 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is between stage I and III, or it's stage IV but being treated to cure it.I am receiving or will start taxane-based chemotherapy at VCU Health Massey Cancer Center.I have been diagnosed with neuropathy.I am currently prescribed Vitamin D.I have been diagnosed with hyperparathyroidism.I cannot communicate in English.My kidney function is severely reduced.
Research Study Groups:
This trial has the following groups:- Group 1: Observation Arm
- Group 2: Vitamin D Replacement
- Group 3: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are currently seeking participants for this clinical trial?
"The clinicaltrials.gov website shows that this study is not recruiting patients at the moment. The trial was first advertised on October 30th 2022 and the most recent update was September 26th 2022. There are 168 other trials which are currently looking for participants to enroll."
Answered by AI
Has the FDA cleared Ergocalciferol Capsules for human use?
"Ergocalciferol Capsules, which are currently in Phase 2 clinical trials, have some evidence supporting their safety but not yet efficacy. Therefore, they were given a score of 2."
Answered by AI
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