Vitamin D Supplementation for Vitamin D Deficiency

Overseen By Kyra Jeanine Solis, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Texas Southwestern Medical Center

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how different doses of Vitamin D affect recovery in burn patients with Vitamin D deficiency. Participants will randomly receive either a low dose (400 IU) or a high dose (4000 IU) of Vitamin D daily. Researchers will assess physical, mental, and social health, among other factors, to understand the vitamin's impact on healing and well-being. The trial seeks adults who have experienced significant burns, undergone surgery for wound closure, and are currently low in Vitamin D. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, helping researchers understand its benefits for more patients.

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 is the safety track record for Ergocalciferol Capsules?

Research shows that Vitamin D is generally safe for most people when taken in normal amounts. However, higher doses, such as 4000 IU daily, might cause side effects. Excessive Vitamin D can lead to nausea, vomiting, or kidney problems.

Studies have found that very high blood levels of Vitamin D can lead to toxicity, which is rare but serious. Most people tolerate the doses used in studies like this well, without serious problems.

In this study, the lower dose of 400 IU is the recommended amount and is considered very safe. Researchers are testing the higher dose of 4000 IU to determine if it provides more benefits without causing harm. Anyone who has had a reaction to Vitamin D or has high calcium levels should consult a doctor before joining a trial like this. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because they explore different doses of ergocalciferol, a form of vitamin D, to combat vitamin D deficiency. Unlike typical over-the-counter vitamin D supplements, which often provide a standard dose, this study looks at the effects of both a low-dose (400 IU) and a high-dose (4000 IU) regimen. The high-dose treatment is particularly compelling as it could potentially offer more rapid and robust correction of deficiency, which might benefit those with significant deficiencies or specific medical conditions requiring higher levels of vitamin D. This approach provides a tailored supplementation strategy that could optimize health outcomes more effectively than current one-size-fits-all solutions.

What evidence suggests that this treatment might be an effective treatment for Vitamin D deficiency?

This trial will compare the effects of low-dose and high-dose vitamin D2 supplementation. Research has shown that high doses of vitamin D2 can increase vitamin D levels in the blood. Specifically, studies found that a daily dose of 4000 IU, which participants in the high-dose arm of this trial will receive, can significantly raise levels of vitamin D, particularly the active form called 25(OH)D2. This higher dose might enhance overall health, including physical and mental well-being. However, vitamin D2 may not perform as effectively as vitamin D3 in some aspects. Overall, evidence supports that high-dose vitamin D2 can effectively boost vitamin D levels in the body. ^{6 7 8 9 10}

Who Is on the Research Team?

Maria Pia Kabamalan

Principal Investigator

UT Southwestern

Are You a Good Fit for This Trial?

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

Vitamin D deficiency

I need surgery for wounds caused by electrical or lightning injuries.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Ergocalciferol Capsules

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.

How Is the Trial Designed?

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 United States, European Union, Canada for the following indications:

Approved in United States as Ergocalciferol for:

• Rickets
• Osteomalacia
• Hypoparathyroidism
• Vitamin D deficiency

Approved in European Union as Ergocalciferol for:

• Rickets
• Osteomalacia
• Hypoparathyroidism
• Vitamin D deficiency

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6152545/

Effects of a 10-day course of a high dose calciferol versus ... The findings of this study reveal that vitamin D2 when given as a single 600 000 IU dose was not effective in correcting the vitamin D status.

2. med.virginia.edu med.virginia.edu/ginutrition/wp-content/uploads/sites/199/2021/06/May-2021-Vitamin-D-Replacement.pdf

Vitamin D Replacement in Adults Once replete, the vitamin D dose is reduced to a maintenance regimen generally of 2,000 IU/day cholecalciferol, or 50,000 IU of ergocalciferol (or ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8538717/

Relative Efficacy of Vitamin D2 and Vitamin D3 in Improving ... Ergocalciferol is less effective than cholecalciferol in elevating total 25(OH)D, and ergocalciferol reduces hydroxylation of vitamin D3 and 25(OH)D3. Armas, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0039128X24000321

Review The effect of vitamin D2 supplementation on ... This meta-analysis indicates that the supplementation of vitamin D2 significantly increases the serum concentrations of total vitamin D, 25(OH)D2, and 1,25(OH)D ...

5. academic.oup.com academic.oup.com/edrv/article/45/5/625/7659127

Consensus Statement on Vitamin D Status Assessment and ... The tolerability and biochemical effects of high-dose bolus vitamin D2 and D3 supplementation in patients with vitamin D insufficiency.

6. mayoclinic.org mayoclinic.org/drugs-supplements/ergocalciferol-oral-route/description/drg-20523253

Ergocalciferol (oral route) - Side effects & dosage Ergocalciferol oral liquid is a dietary supplement that is used to treat vitamin D deficiency. This medicine is available both over-the-counter (OTC) and with ...

7. ods.od.nih.gov ods.od.nih.gov/factsheets/VitaminD-HealthProfessional/

Vitamin D - Health Professional Fact Sheet Vitamin D overview for health professionals. Research health effects, dosing, sources, deficiency symptoms, side effects, and interactions here.

8. my.clevelandclinic.org my.clevelandclinic.org/health/diseases/15050-vitamin-d-vitamin-d-deficiency

Vitamin D Deficiency: Causes, Symptoms & Treatment Vitamin D deficiency means that you don't have enough vitamin D in your body. It's common and primarily causes issues with your bones and muscles.

9. drugs.com drugs.com/mtm/vitamin-d2.html

Vitamin D2 Uses, Side Effects & Warnings You should not take ergocalciferol if you have had an allergic reaction to vitamin D, or if you have high levels of calcium or vitamin D in your ...

10. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK532266/

Vitamin D Deficiency - StatPearls - NCBI Bookshelf Although the maximum safe upper level of serum 25-hydroxyvitamin D is not well-established, levels above 100 ng/mL may pose a risk of toxicity ...