Vitamin D for Sarcoidosis

Overseen By Khashayar Sakhaee, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Infection, Inflammatory disease, Malignancy, others

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: 12

Duration: 24 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how vitamin D levels affect sarcoidosis, a condition where the immune system overreacts, forming cell lumps in organs. Researchers are testing whether vitamin D supplements can aid those with sarcoidosis and low vitamin D levels. Participants will receive either vitamin D2 (ergocalciferol) or a placebo to determine its impact on their condition. Individuals with sarcoidosis and low vitamin D, who haven't been hospitalized or had emergency visits in the past three months, might be suitable for this trial. As a Phase 4 trial, the research focuses on understanding how the already FDA-approved treatment can benefit more patients with sarcoidosis.

Do I need to stop my current medications for the trial?

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 these treatments?

Research has shown that ergocalciferol, a type of vitamin D, is commonly used to treat vitamin D deficiency. However, limited information exists about its safety for individuals with sarcoidosis. One study examined calcium and vitamin D issues in people with sarcoidosis to assess the safety of supplements. The results indicated no clear evidence that vitamin D supplements are harmful to these patients.

Ergocalciferol is often used for other health issues and is generally well-tolerated. Some individuals might experience mild stomach upset or allergic reactions, but serious side effects are rare. As this is a Phase 4 trial, earlier studies have already tested ergocalciferol for safety, and it is considered safe for humans. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for sarcoidosis involve the use of systemic corticosteroids, which work by reducing inflammation but can have significant side effects. However, Ergocalciferol, a form of vitamin D2, is unique because it targets low vitamin D levels in patients. This treatment is exciting because it offers a potentially safer alternative to steroids by addressing vitamin D deficiency, which might play a role in the disease. Researchers are hopeful that supplementing with Ergocalciferol can help manage sarcoidosis symptoms with fewer side effects, giving patients a more comfortable treatment option. Moreover, this approach could improve overall bone health, a common concern for patients taking long-term corticosteroids.

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

Research has shown that people with sarcoidosis often have low vitamin D levels, with 47% experiencing a severe deficiency. Vitamin D is crucial for maintaining strong bones and supporting the immune system. In sarcoidosis, low vitamin D can worsen the disease. This trial will compare different methods for managing vitamin D levels. Participants with low vitamin D will receive either ergocalciferol or a placebo, while those with normal levels will receive calcium citrate with vitamin D2. Studies have explored using vitamin D supplements, like ergocalciferol, to address these deficiencies. However, excessive vitamin D in people with sarcoidosis can increase calcium levels, leading to health issues. Therefore, while vitamin D may be beneficial, careful monitoring is essential for those with sarcoidosis. ^{1 3 5 6 7}

Who Is on the Research Team?

Connie Hsia, MD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for sarcoidosis patients with low vitamin D levels who haven't been hospitalized or visited the ER in the past 3 months, have no other inflammatory diseases, infections, cancer, and normal calcium levels in their blood.

Inclusion Criteria

I do not have any ongoing lung or body-wide infections.

Normal serum ionized calcium level

I haven't been hospitalized or visited the ER in the last 3 months.

Exclusion Criteria

I currently have an infection in my lungs or elsewhere in my body.

I have not been to the hospital or emergency room in the last 3 months.

Elevated serum ionized calcium level

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vitamin D supplementation or placebo. Low vitamin D group receives Ergocalciferol 50,000 units weekly for 12 weeks, then monthly for 12 weeks. All groups receive daily calcium citrate with vitamin D2 for 24 weeks.

24 weeks

Weekly visits for 12 weeks, then monthly visits for 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Calcium Citrate with Vitamin D2
• Ergocalciferol
• Placebo

Trial Overview The study is testing if standard vitamin-D supplements can help manage sarcoidosis better than a placebo. Patients are split into two groups: one gets real supplements and the other gets a fake pill (placebo).

How Is the Trial Designed?

Group I: Normal vit-D, control Experimental Treatment 1 Intervention

Normal serum vitamin D level, split by use or non-use of systemic corticosteroid. Daily dietary requirement (calcium citrate with vitamin D2 (200 mg/250 Units tablets, 4 tablets per day) will be given by mouth for 24 weeks).

Group II: Low vit-D, Ergocalciferol Experimental Treatment 2 Interventions

Low serum vitamin D level, split by use or non-use of systemic corticosteroid. Vitamin D2 (Ergocalciferol) 50,000 units will be given by mouth once a week for 12 weeks, then once a month for 12 weeks. Daily dietary requirement (calcium citrate with vitamin D2 (200 mg/250 Units tablets, 4 tablets per day) will be given by mouth for 24 weeks).

Group III: Low vit-D, Placebo Placebo Group 2 Interventions

Low serum vitamin D level, split by use or non-use of systemic corticosteroid. Placebo capsules of identical size and appearance will be given by mouth once a week for 12 weeks, then once a month for 12 weeks. Daily dietary requirement (calcium citrate with vitamin D2 (200 mg/250 Units tablets, 4 tablets per day) will be given by mouth for 24 weeks).

Ergocalciferol 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

In sarcoidosis, granulomatous inflammation disrupts normal vitamin D synthesis, leading to increased levels of 1,25-dihydroxyvitamin D, which may affect immune responses.

Vitamin D acts as an immunomodulator, inhibiting antigen presentation and Th1 cell activity, suggesting that monitoring and supplementing vitamin D could be beneficial for managing immune health in sarcoidosis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calcium and vitamin D in sarcoidosis: how to assess and manage. Burke, RR., Rybicki, BA., Rao, DS.[2022]

In a randomized, placebo-controlled trial involving 27 patients with sarcoidosis and low vitamin D levels, vitamin D supplementation did not significantly change serum calcium levels or improve markers of skeletal health over 12 months.

Despite increasing vitamin D levels in participants, the supplementation led to one case of significant hypercalcemia, highlighting potential risks associated with vitamin D intake in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of vitamin D supplementation in sarcoidosis. Bolland, MJ., Wilsher, ML., Grey, A., et al.[2022]

Sarcoidosis can cause abnormal calcium metabolism, leading to conditions like hypercalcemia and kidney stones due to increased 1α-hydroxylase activity in macrophages, which raises calcitriol levels.

Vitamin D supplementation is risky for some sarcoidosis patients and should only be given to those with low 25-hydroxyvitamin D and normal calcitriol levels, highlighting the need for careful management of bone health in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balancing Altered Calcium Metabolism with Bone Health in Sarcoidosis. Zhou, Y., Lower, EE.[2021]

In a study of 142 patients with sarcoidosis, 23.5% experienced fragility fractures despite having normal bone mineral density (BMD), indicating that factors other than BMD contribute to fracture risk.

Low dietary calcium, high corticosteroid use, and specific serum vitamin D levels were linked to increased fracture risk, suggesting that vitamin D and calcium supplementation should be carefully managed in sarcoidosis patients to avoid potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone fragility in sarcoidosis and relationships with calcium metabolism disorders: a cross sectional study on 142 patients. Saidenberg-Kermanac'h, N., Semerano, L., Nunes, H., et al.[2022]

A study of sarcoidosis patients revealed that maintaining vitamin D levels between 10 and 20 ng/ml is associated with the lowest risk of bone fractures, highlighting the importance of optimal vitamin D levels for bone health.

Excessively high levels of vitamin D were found to paradoxically increase the risk of bone fractures, suggesting that reducing vitamin D supplementation could help lower both fracture risk and the potential for hypercalcemia in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goldilocks, vitamin D and sarcoidosis. Baughman, RP., Lower, EE.[2022]

In a study of 64 sarcoidosis patients, 64% had low levels of 25(OH) Vitamin D, with a significant association found between deficiency and African-American race, indicating a need for targeted monitoring in this group.

Despite the prevalence of Vitamin D deficiency, the elevated levels of 1,25(OH)2D in sarcoidosis patients suggest that Vitamin D supplementation could be harmful due to the risk of hypercalcemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitamin D status in sarcoidosis: a cross-sectional study. Papanikolaou, IC., Tabila, B., Tabila, K., et al.[2020]

In a study of 196 sarcoidosis patients, those who received vitamin D supplementation had a significantly higher incidence of hypercalcemia (42.3%) compared to those who did not receive supplementation (18.3%), indicating a potential safety concern with vitamin D use in this population.

Many patients receiving vitamin D did not have adequate blood work done prior to supplementation, which increases the risk of hypercalcemia, especially in those with renal failure, highlighting the need for proper monitoring before prescribing vitamin D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitamin D Supplementation: Not So Simple in Sarcoidosis. Sodhi, A., Aldrich, T.[2022]

Patients with sarcoidosis often have low levels of vitamin D-25, which is crucial for bone health, and this deficiency may contribute to the disease's autoimmune aspects.

Corticosteroid treatment for sarcoidosis can lead to osteoporosis, highlighting the need for careful management of bone health in these patients due to multiple factors including vitamin D deficiency and granuloma formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone health issues in sarcoidosis. Sweiss, NJ., Lower, EE., Korsten, P., et al.[2022]

Vitamin D, particularly its active form 1,25-dihydroxyvitamin D, has shown potential in modulating the immune response in sarcoidosis by enhancing innate immunity and reducing autoimmune reactions, which could be beneficial for treatment.

While vitamin D supplementation in sarcoidosis patients raises concerns about hypercalcemia, recent studies suggest that it may not significantly increase serum calcium levels, although cases of hypercalciuria have been reported, indicating a need for careful monitoring and further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of vitamin D in sarcoidosis. Gianella, F., Hsia, CC., Sakhaee, K.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7886067/

The role of vitamin D in sarcoidosis - PMC Results showed severe vitamin D deficiency in 47% of patients with sarcoidosis compared with 3% in those with tuberculosis. Moreover, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03621553

NCT03621553 | Vitamin D Homeostasis in Sarcoidosis This study evaluates the relationship between vitamin-D status and severity of sarcoidosis, and the effects of vitamin-D repletion in vitamin-D insufficient ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4876288/

Calcium and Vitamin D in Sarcoidosis: How to Assess and ... Despite near universal vitamin D deficiency, 71% of the patients (41/58) had serum 1, 25-dihydroxyvitamin D levels at or above the median clinical value (33.5 ...

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/180401

Vitamin D Homeostasis in Sarcoidosis This study evaluates the relationship between vitamin-D status and severity of sarcoidosis, and the effects of vitamin-D repletion in ...

5. withpower.com withpower.com/trial/phase-4-sarcoidosis-6-2010-b4585

Vitamin D for Sarcoidosis Vitamin D supplementation can be dangerous for people with sarcoidosis because it may lead to high calcium levels in the blood, which can cause health problems.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03621553

NCT03621553 | Vitamin D Homeostasis in Sarcoidosis This study evaluates the relationship between vitamin-D status and severity of sarcoidosis, and the effects of vitamin-D repletion in vitamin-D insufficient ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/jbmr.2262

Calcium and Vitamin D in Sarcoidosis: Is Supplementation ... We studied calcium and vitamin D disorders in a large cohort of sarcoidosis patients and investigated if CAD supplementation is safe.