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

Trial Summary

What is the purpose of this trial?

This study evaluates the relationship between vitamin-D status and severity of sarcoidosis, and the effects of vitamin-D repletion in vitamin-D insufficient patients with sarcoidosis. Half the patients with sarcoidosis who are vitamin-D insufficient will receive standard vitamin-D supplementation via standard regimen while the other half will receive a placebo. Sarcoidosis patients who are vitamin-D sufficient will also act as controls.

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 data supports the effectiveness of the drug Calcium Citrate with Vitamin D2 for sarcoidosis?

The research suggests that vitamin D supplementation in sarcoidosis can be risky due to the potential for increased calcium levels in the blood, which can be harmful. Therefore, while vitamin D has general health benefits, its use in sarcoidosis patients should be approached with caution. ^{1 2 3 4 5}

Is Vitamin D supplementation safe for people with 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. It's important for sarcoidosis patients to be cautious with Vitamin D supplements and consult their doctor. ^{1 2 3 6 7}

How does the drug Ergocalciferol differ from other treatments for sarcoidosis?

Ergocalciferol (Vitamin D2) is unique in sarcoidosis treatment because it addresses vitamin D deficiency, which is common in these patients, but must be used cautiously due to the risk of hypercalcemia (high calcium levels in the blood) caused by increased vitamin D activity in sarcoidosis. Unlike standard treatments like glucocorticoids, which have many side effects, Ergocalciferol may help modulate the immune system and improve bone health, but its use requires careful monitoring. ^{1 2 7 8 9}

Research Team

Connie Hsia, MD

Principal Investigator

University of Texas Southwestern Medical Center

Eligibility Criteria

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.

I have an active inflammatory condition.

Timeline

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Vitamin D status in sarcoidosis: a cross-sectional study. [2020]

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

Vitamin D Supplementation: Not So Simple in Sarcoidosis. [2022]

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

Randomised controlled trial of vitamin D supplementation in sarcoidosis. [2022]

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

Bone fragility in sarcoidosis and relationships with calcium metabolism disorders: a cross sectional study on 142 patients. [2022]

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

Calcium and vitamin D in sarcoidosis: how to assess and manage. [2022]

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

Balancing Altered Calcium Metabolism with Bone Health in Sarcoidosis. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Goldilocks, vitamin D and sarcoidosis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The role of vitamin D in sarcoidosis. [2021]

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

Bone health issues in sarcoidosis. [2022]