Vitamin D Supplementation for Vitamin D Deficiency

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Parathyroid disease, Liver dysfunction, Kidney dysfunction, Malignant tumors, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing if giving burn patients with low Vitamin D a higher amount of Vitamin D improves their health more than a smaller amount. The study focuses on physical, mental, and social health outcomes. Vitamin D deficiency is common in burn patients, and previous studies have shown that supplementation may improve health outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Ergocalciferol Capsules for Vitamin D deficiency?

Research shows that ergocalciferol (vitamin D2) at a dose of 50,000 IU three times weekly for four weeks effectively and safely corrects low vitamin D levels in nursing home residents. ^{1 2 3 4 5}

Is vitamin D supplementation safe for humans?

Vitamin D supplementation is generally safe for humans when taken in recommended doses, but taking too much can lead to problems like high calcium levels in the blood. It's important to follow guidelines and avoid very high doses over a long period. ^{3 5 6 7 8}

How does the drug Ergocalciferol differ from other vitamin D treatments for deficiency?

Ergocalciferol (vitamin D2) is a synthetic form of vitamin D that is less stable and less potent than cholecalciferol (vitamin D3), which is the natural form found in the body. Unlike vitamin D3, ergocalciferol has a shorter shelf life and is more susceptible to breakdown, making it less effective for long-term supplementation. ^{2 3 5 6 9}

Research Team

Maria Pia Kabamalan

Principal Investigator

UT Southwestern

Eligibility Criteria

This trial is for adults with major burn injuries who have a vitamin D deficiency. Eligible participants are those aged 18-64 with burns covering at least 20% of their body, or those aged 65 and older with at least 10% coverage. They must be past the six-month mark from their injury and able to speak English or Spanish. People with cancer, parathyroid disease, severe liver or kidney dysfunction unrelated to burns cannot join.

Inclusion Criteria

I can communicate in English or Spanish.

I am over 65 and need surgery for a burn that covers 10% or more of my body.

Vitamin D deficiency

Exclusion Criteria

I have severe liver or kidney problems not caused by a burn injury.

Patients not meeting the inclusion criteria

I have a cancerous tumor.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a low dose (400 IU) or high dose (4000 IU) of Vitamin D daily

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Ergocalciferol Capsules (Vitamin D Supplement)

Trial Overview The study tests two doses of Vitamin D (400 IU vs. 4000 IU daily) in burn patients deficient in Vitamin D. It's a double-blind trial where neither the researchers nor participants know who gets which dose until after the results are collected. The main focus is on how these doses affect physical, mental, and social health as well as itchiness related to burns.

Participant Groups

Group I: High-dose Experimental Treatment 1 Intervention

4000 IU Per Orem

Group II: Low-dose Active Control 1 Intervention

400 IU Per Orem

Ergocalciferol Capsules is already approved in Canada for the following indications:

Approved in Canada as Ergocalciferol for:

• Rickets
• Osteomalacia
• Hypoparathyroidism
• Vitamin D deficiency

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Daniel K. Podolsky

University of Texas Southwestern Medical Center

Chief Executive Officer since 2008

MD from Harvard Medical School

Robert L. Bass

University of Texas Southwestern Medical Center

Chief Medical Officer since 2019

MD from University of Texas Southwestern Medical School

Findings from Research

An 84-year-old patient was mistakenly given ergocalciferol (vitamin D2) at a daily dose instead of the intended weekly dose, leading to a significant increase in vitamin D levels from < 7.0 ng/mL to 100 ng/mL over six months, which highlights the importance of accurate dosing in vitamin D therapy.

The patient experienced adverse effects, including decreased appetite and weight loss, demonstrating that while vitamin D is crucial for health, excessive supplementation can lead to toxicity, emphasizing the need for careful monitoring and appropriate dosing, especially in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitamin D deficiency: appropriate replenishment therapies and the effects of vitamin D toxicity. Carlton, S., Clopton, D., Cappuzzo, KA.[2010]

In a study of 279 adults, both vitamin D2 and D3 supplements significantly increased 25-hydroxy D levels compared to placebo, with the highest increases observed in those taking D3 on a 2-weekly schedule.

The effectiveness of vitamin D2 and D3 in raising 25-hydroxy D levels was found to be influenced by dosing schedule and sex, with females showing a greater response to both forms of vitamin D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential effects of vitamin D2 and D3 supplements on 25-hydroxyvitamin D level are dose, sex, and time dependent: a randomized controlled trial. Hammami, MM., Yusuf, A.[2018]

Cholecalciferol (vitamin D3) is the most effective and stable form of vitamin D for supplementation, while ergocalciferol (vitamin D2) is less potent and more prone to degradation during storage and cooking.

Current nutrition guidelines often overlook that calcidiol and calcitriol are not nutrients suitable for food fortification or dietary supplementation, emphasizing the need to focus on cholecalciferol for effective vitamin D intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitamin D supplementation: cholecalciferol, calcifediol, and calcitriol. Vieth, R.[2021]

A study involving 63 nursing home residents found that taking ergocalciferol (vitamin D2) at a high dose of 50,000 IU three times a week for four weeks effectively increased vitamin D levels from an average of 17.3 to 63.8 ng/ml in those with low vitamin D status.

The treatment was safe, with no adverse effects like hypercalcemia reported, although it did not lead to improvements in mobility, cognition, or behavior among the participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid correction of low vitamin D status in nursing home residents. Przybelski, R., Agrawal, S., Krueger, D., et al.[2021]

Calcidiol (25-hydroxy-vitamin D) is a beneficial form of vitamin D supplementation, especially for patients with liver disease, obesity, or intestinal malabsorption, due to its favorable pharmacokinetic properties.

The ADDI-D study found that a daily dose of 40 μg of calcidiol is more effective in raising vitamin D levels in severely deficient patients compared to lower doses, while a weekly dose of 125 μg can be a good option for those struggling with daily compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral calcidiol is a good form of vitamin D supplementation. Biondi, P., Pepe, J., Biamonte, F., et al.[2020]

In a study involving 50 patients on continuous ambulatory peritoneal dialysis (CAPD), both weekly split doses and single doses of ergocalciferol (60,000 IU) effectively increased serum 25-hydroxyvitamin D levels, indicating that either dosing strategy can be used for vitamin D repletion.

No significant adverse effects, such as hypercalcemia or hyperphosphatemia, were reported, suggesting that ergocalciferol supplementation is safe for patients on CAPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Weekly Split versus Single Doses of Ergocalciferol on Serum 25-Hydroxyvitamin D among Patients on Continuous Ambulatory Peritoneal Dialysis: A Randomized Controlled Trial. Nata, N., Kanchanasinitth, J., Tasanavipas, P., et al.[2022]

The commonly accepted upper limit of 4000 IU/day for vitamin D supplementation may not adequately reflect the risks of adverse effects, suggesting that the therapeutic window for vitamin D could be narrower than previously thought.

Daily doses of 800-1000 IU of vitamin D or 10 µg of calcifediol are considered safe for preventing or correcting deficiency, while larger doses over long periods or in intermittent regimens should be avoided due to potential harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitamin D supplementation: upper limit for safety revisited? Rizzoli, R.[2021]

Vitamin D supplementation is common due to the high prevalence of low vitamin D levels, but both low and high levels of vitamin D can pose health risks, indicating a 'U-shaped' relationship.

While low vitamin D levels are well-studied for their adverse effects, the potential risks associated with high levels of vitamin D supplementation in healthy adults are less understood and need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: higher vitamin D status and supplementation may be associated with risks. Korgavkar, K., Xiong, M., Weinstock, MA.[2014]

Vitamin D3 (cholecalciferol) is more effective than Vitamin D2 (ergocalciferol) in raising serum levels of 25-hydroxyvitamin D, which is a key measure of vitamin D status in the body.

Due to its superior bioefficacy, Vitamin D2 should not be considered a suitable option for supplementation or fortification, as it has a shorter shelf life and less effective binding to vitamin D binding protein in plasma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The case against ergocalciferol (vitamin D2) as a vitamin supplement. Houghton, LA., Vieth, R.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Vitamin D deficiency: appropriate replenishment therapies and the effects of vitamin D toxicity. [2010]

2. England pubmed.ncbi.nlm.nih.gov

Differential effects of vitamin D2 and D3 supplements on 25-hydroxyvitamin D level are dose, sex, and time dependent: a randomized controlled trial. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Vitamin D supplementation: cholecalciferol, calcifediol, and calcitriol. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Rapid correction of low vitamin D status in nursing home residents. [2021]

5. Italy pubmed.ncbi.nlm.nih.gov

Oral calcidiol is a good form of vitamin D supplementation. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Weekly Split versus Single Doses of Ergocalciferol on Serum 25-Hydroxyvitamin D among Patients on Continuous Ambulatory Peritoneal Dialysis: A Randomized Controlled Trial. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Vitamin D supplementation: upper limit for safety revisited? [2021]

8. France pubmed.ncbi.nlm.nih.gov

Review: higher vitamin D status and supplementation may be associated with risks. [2014]

9. United States pubmed.ncbi.nlm.nih.gov

The case against ergocalciferol (vitamin D2) as a vitamin supplement. [2023]