Vitamin D for Sarcoidosis
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: Infection, Inflammatory disease, Malignancy, others
Prior Safety Data
Approved in 3 Jurisdictions
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?
Is Vitamin D supplementation safe for people with sarcoidosis?
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.12789
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.
See 2 more
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.
See 2 more
Trial 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 (Vitamin Supplement)
- Ergocalciferol (Vitamin Supplement)
- Placebo (Placebo)
Trial OverviewThe 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
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Normal vit-D, controlExperimental Treatment1 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, ErgocalciferolExperimental Treatment2 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, PlaceboPlacebo Group2 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Texas Southwestern Medical Center, and Parkland Health and Hospital SystemDallas, TX
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Who Is Running the Clinical Trial?
University of Texas Southwestern Medical CenterLead Sponsor
References
Vitamin D status in sarcoidosis: a cross-sectional study. [2020]Background: Hypercalcemia, a common feature in sarcoidosis, is due to the excessive production of active Vitamin D metabolite, 1,25(OH)2D. Levels of 25(OH) Vitamin D however may not be appropriate. Objectives: To assess Vitamin D status and its clinical associations in sarcoidosis patients compared to a general respiratory diseases out-patient clinic population, serving as controls. Methods: 64 sarcoidosis cases and 53 control cases with other than sarcoidosis respiratory diseases, matched for age and sex were included in the study. Serum 25(OH)D, 1,25(OH)2D, calcium, angiotensin converting enzyme (ACE) were measured. 25(OH) Vitamin D was described as deficient when <20 ng/ml and insufficient when <30 ng/ml. Clinical parameters were recorded for sarcoidosis cases. Results: Overall 41/64 sarcoidosis cases (64%) had low 25(OH) D, 7/64 (11%) had high 1,25(OH)2D and 2/64 had hypercalcaemia (3%). Sarcoidosis subjects likely exhibited deficient (39%) or normal 25(OH)D levels (36%) in comparison to controls (p=0.018). 25(OH) Vitamin D deficiency in sarcoidosis was associated with race and radiological stage I disease, with regression analysis identifying African-American race as the only significant risk factor (p=0.03). An inverse correlation between ACE and 25(OH)D levels was found (p=0.052). 1,25(OH)2D was significantly elevated in sarcoidosis compared to controls. Among sarcoidosis patients, those with insufficient 25(OH)D levels exhibited higher calcium levels in serum. Conclusions: 25(OH) Vitamin D deficiency is prevalent in sarcoidosis, particularly in African-Americans and likely those with active disease. However, concomitant 1,25(OH)2D elevation and associated hypercalcaemia make Vitamin D supplementation dangerous in sarcoidosis. (Sarcoidosis Vasc Diffuse Lung Dis 2018; 35: 154-159).
Vitamin D Supplementation: Not So Simple in Sarcoidosis. [2022]Americans are increasingly receiving vitamin D supplementation, often based on low-measured 25-hydroxy-vitamin D (25-OH-vit D). In sarcoidosis, there is often increased metabolism of 25-OH-vit D to 1,25-dihydroxy-vitamin D (1,25-OH-vit D), so 25-OH-vit D may remain low, despite high levels of 1,25-OH-vit D. In such cases, vitamin D supplementation may lead to hypercalcemia.
Randomised controlled trial of vitamin D supplementation in sarcoidosis. [2022]The role vitamin D intake/production plays in sarcoidosis-associated hypercalcaemia is uncertain. However, authoritative reviews have recommended avoiding sunlight exposure and vitamin D supplements, which might lead to adverse skeletal outcomes from vitamin D insufficiency. We investigated the effects of vitamin D supplementation on surrogate measures of skeletal health in patients with sarcoidosis and vitamin D insufficiency.
Bone fragility in sarcoidosis and relationships with calcium metabolism disorders: a cross sectional study on 142 patients. [2022]The prevention of fragility fractures in patients with sarcoidosis is a serious concern and the potential risk of hypercalcemia limits vitamin D and calcium supplementation. The objective of this study was to evaluate the risk factors for low bone mineral density (BMD) and fractures in sarcoidosis. In particular, we aimed to determine the link among bone fragility and calcium and vitamin D metabolism in this population.
Calcium and vitamin D in sarcoidosis: how to assess and manage. [2022]The synthesis of vitamin D is altered by the granulomatous inflammation of sarcoidosis leading to increased production of 1, 25-dihydroxyvitamin D. Mounting evidence suggests that vitamin D is an immunomodulating hormone that inhibits both antigen presentation by cells of the innate immune system, and the cytokine release and proliferation of Th1 cells. These and other extraskeletal health benefits have led to an increase in vitamin D assessment and pharmacological supplementation in the general population. This review highlights the altered synthesis and general immunomodulating properties of vitamin D with a special emphasis on known interactions with sarcoidosis. In addition, the assessment of vitamin D nutritional status, its pharmacological supplementation, and the management of bone health in patients with sarcoidosis are reviewed.
Balancing Altered Calcium Metabolism with Bone Health in Sarcoidosis. [2021]Abnormal calcium metabolism in sarcoidosis patients can lead to hypercalcemia, hypercalciuria, and kidney stones. Hypercalcemia in sarcoidosis is usually due to increased activity of 1α-hydroxylase in macrophages of pulmonary granulomata, resulting in low levels of 25-hydroxyvitamin D and high levels of calcitriol. Vitamin D supplementation may be dangerous for some sarcoidosis patients and is recommended only for those with decreased 25-hydroxyvitamin D and reduced or normal calcitriol level. Diagnosis, treatment of osteoporosis, and maintenance of bone health are complex issues for sarcoidosis patients. An approach to diagnosis and treatment of bone fragility is presented.
Goldilocks, vitamin D and sarcoidosis. [2022]While low levels of vitamin D can increase the risk for osteoporosis, excessive amounts of vitamin D may also be problematic. Hypercalcemia and hypercalcuria due to increased vitamin D activity occur in a significant proportion of sarcoidosis patients. Saidenberg-Kermanac’h and colleagues compared vitamin D levels with bone fragility fractures in their sarcoidosis clinic.They found that a 25-(OH) vitamin D level between 10 and 20 ng/ml was associated with the lowest risk of bone fractures and paradoxically higher levels increased the risk of bone fractures. Using less vitamin D supplementation may simultaneously lower the risk for bone fracture and hypercalcemia in sarcoidosis.
The role of vitamin D in sarcoidosis. [2021]After the initial description of extrarenal synthesis of 1,25-dihydroxyvitamin D (1,25-(OH)2D) three decades ago, extensive progress has been made in unraveling the immunomodulatory roles of vitamin D in the pathogenesis of granulomatous disorders, including sarcoidosis. It has been shown that 1,25-(OH)2D has dual effects on the immune system, including upregulating innate immunity as well as downregulating the autoimmune response. The latter mechanism plays an important role in the pathogenesis and treatment of sarcoidosis. Vitamin D supplementation in patients with sarcoidosis has been hampered owing to concerns about the development of hypercalcemia and hypercalciuria given that extrarenal 1-α hydroxylase is substrate dependent. Recently, a few studies have cast doubt over the mechanisms underlying the development of hypercalcemia in this population. These studies demonstrated an inverse relationship between the level of vitamin D and severity of sarcoidosis. Consequently, clinical interest has been piqued in the use of vitamin D to attenuate the autoimmune response in this disorder. However, the development of hypercalcemia and the attendant detrimental effects are real possibilities. Although the average serum calcium concentration did not change following vitamin D supplementation, in two recent studies, hypercalciuria occurred in one out of 13 and two out of 16 patients. This review is a concise summary of the literature, outlining past work and newer developments in the use of vitamin D in sarcoidosis. We feel that larger-scale placebo-controlled randomized studies are needed in this population. Since the current first-line treatment of sarcoidosis is glucocorticoids, which confer many systemic adverse effects, and steroid-sparing immunosuppressant treatment options carry additional risks of adverse effects, adjunct management with vitamin D in combination with potent anti-osteoporotic medications could minimize the risk of glucocorticoid-induced osteoporosis and modulate the immune system to attenuate disease activity in sarcoidosis.
Bone health issues in sarcoidosis. [2022]Sarcoidosis affects the bone directly in only a minority of patients. Nonetheless, bone health should be considered in the management of all patients with sarcoidosis. Deficiency in vitamin D, an important contributor to bone health, has been linked to autoimmune disease incidence. Studies have shown that patients with sarcoidosis frequently have low levels of vitamin D-25 but may have normal or increased levels of vitamin D-1,25. In addition, granuloma formation has been linked to a failure of the innate immune system, which could be related to a deficiency in vitamin D, although this relationship has not been fully characterized. Furthermore, many patients with sarcoidosis are treated with corticosteroids, which are known to induce osteoporosis. Therefore, bone health may be impacted in several ways in sarcoidosis--by direct involvement with granulomas, vitamin D deficiency, or corticosteroid therapy.