Vitamin D Supplements for Neuropathic Pain

Overseen By Susan Hong, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Virginia Commonwealth University

Must be taking: Vitamin D

Must not be taking: Prescription Vitamin D

Disqualifiers: Neuropathy, Pregnancy, Chronic kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 24 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether vitamin D supplements can reduce nerve pain in individuals with low vitamin D levels who are about to begin taxane-based chemotherapy. Participants will be divided into two groups: one will receive prescribed vitamin D supplements (such as Cholecalciferol Capsules or Ergocalciferol Capsules), while the other will follow regular care advice. The trial seeks individuals with specific types of cancer who will soon start treatment and have low vitamin D levels. The study aims to determine if increasing vitamin D can alleviate some pain often associated with cancer treatment. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications, but you cannot participate if you are already taking prescription Vitamin D.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that vitamin D supplements, such as cholecalciferol and ergocalciferol, are generally safe. These forms of vitamin D effectively address low vitamin levels in the body. Studies have found that side effects are rare when taken as recommended.

Both cholecalciferol and ergocalciferol help boost vitamin D levels. Most side effects, like mild stomach issues, are uncommon and usually not serious.

Since this trial is in an early phase, some evidence of safety exists, but further confirmation is needed. Prospective participants can feel reassured that these supplements are usually safe for most people.

Why do researchers think this study treatment might be promising for neuropathic pain?

Researchers are excited about using vitamin D supplements for neuropathic pain because these treatments could offer a simple and natural alternative to current pain management strategies, which often include medications like anticonvulsants and antidepressants. Unlike these standard treatments that primarily focus on altering nerve signals, vitamin D may help by addressing potential deficiencies that could contribute to nerve pain. By aiming to optimize vitamin D levels in the body, this approach offers a potential new avenue for relief that is both accessible and easy to administer.

What evidence suggests that this trial's treatments could be effective for neuropathic pain?

Research has shown that vitamin D, including ergocalciferol, might help with nerve pain. Studies have found that vitamin D can increase a protein crucial for nerve health, potentially reducing pain. In individuals with diabetic nerve pain, which resembles other types of nerve pain, vitamin D significantly lowered pain levels. Some studies even observed pain relief within a few weeks of taking vitamin D supplements. In this trial, participants in the Vitamin D Replacement arm will receive prescribed oral vitamin D2 to achieve a serum vitamin D level between 30 ng/mL and 50 ng/mL. These findings suggest that vitamin D might also help manage pain for people undergoing chemotherapy. ^{1 2 3 4}

Who Is on the Research Team?

Susan Hong, MD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

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.

Inclusion 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.

Vitamin D serum level <20 ng/mL Note: study participants with Vitamin D serum level ≥20 ng/mL may be enrolled in the observational arm.

Exclusion Criteria

I have been diagnosed with neuropathy.

Pregnancy

Hypercalcemia: Calcium levels >10.5 mg/dL Note: study participants with calcium levels <10.5 mg/dL may be enrolled in the observational arm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either prescribed vitamin D replacement or standard of care advice for vitamin D supplementation

24 weeks

Visits at Weeks 4, 8, 12, and 24 for blood draws and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cholecalciferol Capsules
• Ergocalciferol Capsules

Trial Overview 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.

How Is the Trial Designed?

Group I: Vitamin D Replacement Experimental Treatment 1 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 Arm Active Control 1 Intervention

Observation only

Group III: Standard of Care Active Control 1 Intervention

Participants will receive standard-of-care advice to take over the counter vitamin D.

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7270292/

Vitamin D and Its Potential Interplay With Pain Signaling ... Vitamin D, known for its role in calcium homeostasis and bone metabolism, is thought to be of clinical benefit in treating chronic pain.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4427945/

Vitamin D and Pain: Vitamin D and Its Role in the Aetiology ... In the diabetic neuropathic pain model, Vitamin D supplementation has been shown to increase NGF production and prevent neurotrophic deficits [91].

3. uspharmacist.com uspharmacist.com/article/vitamin-d-and-chronic-pain-promising-correlates

Vitamin D and Chronic Pain: Promising Correlates The results varied from improvement to complete resolution of pain within 3 to 6 weeks.14. Summary of Studies. The studies discussed here ...

4. drc.bmj.com drc.bmj.com/content/4/1/e000148

Vitamin D for the treatment of painful diabetic neuropathy Treatment with a single intramuscular dose of 600 000 IU of vitamin D in patients with painful diabetic neuropathy is associated with a significant decrease in ...