Ergocalciferol for Sarcoidosis

3
Effectiveness
3
Safety
University of Texas Southwestern Medical Center, and Parkland Health and Hospital System, Dallas, TX
Sarcoidosis+1 More
Ergocalciferol - Drug
Eligibility
18+
All Sexes
Eligible conditions
Sarcoidosis

Study Summary

This study is evaluating whether vitamin-D status is associated with sarcoidosis severity.

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Eligible Conditions

  • Sarcoidosis
  • Vitamin D Insufficiency

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Compared to trials

Study Objectives

This trial is evaluating whether Ergocalciferol will improve 1 primary outcome and 16 secondary outcomes in patients with Sarcoidosis. Measurement will happen over the course of Baseline and 24 weeks.

Baseline and 24 weeks
Change in Fluoro-deoxyglucose (FDG) uptake on PET/CT
Change in bone density z-score
Change in fractional lung tissue volume on computed/positron emission tomography (PET/CT)
Change in lung function from baseline
Change in six minute walk distance
Week 24
Change in 24 hour urine calcium/creatinine ratio
Change in 24 hour urine deoxypyridinoline concentration
Change in King's Sarcoidosis Questionnaire Score
Change in blood cell counts from complete blood count (CBC)
Change in metabolic profile from complete metabolic panel (CMP)
Change in serum C-reactive protein (CRP) concentration
Change in serum angiotensin converting enzyme (ACE) concentration
Change in serum interferon-gamma (IFN-gamma) concentration
Change in serum serum gamma-globulin concentration
Change in serum tumor Necrosis factor-alpha (TNF-alpha) concentration
Change in serum vitamin-D metabolite concentration
Changes in serum interleukin concentration

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Low vit-D, Placebo
Low vit-D, Ergocalciferol
Placebo group

This trial requires 90 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ergocalciferol is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Low vit-D, ErgocalciferolLow 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).
Low vit-D, PlaceboLow 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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ergocalciferol
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 12 and 24 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 12 and 24 weeks for reporting.

Who is running the study

Principal Investigator
C. C. W. H.
Prof. Connie C W Hsia, Professor of Internal Medicine
University of Texas Southwestern Medical Center

Closest Location

University of Texas Southwestern Medical Center, and Parkland Health and Hospital System - Dallas, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A person is considered to have a stable medical condition if they have not been hospitalized or gone to the emergency room in the past 3 months. show original
No evidence of active pulmonary or systemic infection
No other active inflammatory disease
There is no active malignancy. show original
Normal serum ionized calcium level

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can sarcoidosis be cured?

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There is no evidence that sarcoidosis can be cured and many patients are left with disabling complications such as pulmonary fibrosis. It is clear that sarcoidosis is best managed with prompt and aggressive intervention and regular, long-term follow-up. It remains an important part of the treatment of sarcoidosis.

Unverified Answer

What is sarcoidosis?

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The word sarcoidosis is hard to pronounce and has no'standard' spelling in English. It is an emergency medicine term. A combination of two Greek words: sarx (σάρξ) meaning flesh, and oudes (οὔδης) meaning belly, together giving sarcoid. Sarcoid, though somewhat a misnomer, is the most widely used term for sarcoidosis in medical literature. However, when the word is used in this sense, it is often mispronounced as sarcan, which leads to a misnomer: sarcofib.

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How many people get sarcoidosis a year in the United States?

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An estimate of prevalence of sarcoidosis in the US is given in the form of the prevalence of sarcoidosis per 100,000 persons per year (PY). In the US, an estimated 100,000 new cases and 50,000 deaths occurred in 2013, while approximately 70,000 US Sarcoidosis cases are diagnosed annually. Sarcoidosis is the second leading cause of bilateral iliopulmonary syndrome (BILS) (i.e.

Unverified Answer

What are common treatments for sarcoidosis?

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We have characterized the treatments used in a large national database for sarcoidosis. In our exploratory analysis on common treatments, we found statistically significant associations between treatment types and clinical and clinical outcome variables. Future randomized controlled trials using standardized treatment dosing schedules are needed to more completely define the role of these specific treatments.

Unverified Answer

What causes sarcoidosis?

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Although the triggers of sarcoidosis are varied, there is a strong genetic component. Sarcoidosis is a complex, multi-factorial disorder that, therefore, requires a multifactorial approach to its treatment.\n

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What are the signs of sarcoidosis?

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Sarcoidosis is an uncommon disease usually diagnosed after the age of 50 years. It can be asymptomatic or can involve a wide variety of organs and produce a wide variety of clinical scenarios. A careful review of the history and physical examination may be useful in determining underlying disease. In sarcoidosis, the classic triad of pulmonary infiltrates, hilar adenopathy, and periadventitial calcinosis may be demonstrable on CT scan.

Unverified Answer

Have there been other clinical trials involving ergocalciferol?

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There were 3 randomized placebo controlled trials published prior to 1990. One trial (569 subjects) involved administering ergocalciferol plus calcium for 1 year, in which 4% experienced skin and non-healing lesions in both cohorts (total 8.2%). The second trial (744) was an open-label trial evaluating the long-term (1 year) effects of administering a similar dose of ergocalciferol plus calcium to those taking a placebo (total 9.7%). A pilot trial had been designed to identify the long-term changes in patients receiving a minimum of 2 years of therapy with low-dose therapy in combination with calcium supplementation (total 4.1%).

Unverified Answer

What is the average age someone gets sarcoidosis?

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My diagnosis is the only experience I've had with sarcoidosis. They told me there were two cases of sarcoidosis in the world. I’m glad that people with sarcoidosis can give us an idea of how they are treated by other doctors around the world.

Unverified Answer

What does ergocalciferol usually treat?

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The treatment of symptomatic sarcoidosis in patients receiving vitamin D therapy needs further evaluation. In a recent study, findings warrant testing vitamin D therapy in patients with sclerosing lymphadenopathy, a common, highly aggressive sarcoid phenotype, to determine the long-term effects of vitamin D.

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Does sarcoidosis run in families?

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Results from a recent clinical trial suggest a genetic component in sarcoidosis and provide further support to the hypothesis that sarcoidosis has a genetic etiology.

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Have there been any new discoveries for treating sarcoidosis?

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A handful of studies show efficacy in slowing disease progression of sarcoidosis, but there have been no controlled studies showing remission with currently used therapies. More controlled studies are necessary to determine effect of treatment in sarcoidosis. Sarcoidosis treatments are limited primarily to corticosteroids; thus, treatments that could inhibit the disease from getting initiated by corticosteroids could not be studied as yet. Further studies of sarcoidosis therapies with regard to treatment failure and severity of disease are essential to developing effective therapies.

Unverified Answer

What are the latest developments in ergocalciferol for therapeutic use?

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Ergocalciferol is effective both in the treatment of sarcoidosis and in the management of osteoporosis. It may provide a treatment alternative in the treatment of both diseases. This treatment should be examined with caution in patients with severe liver disease, gastrointestinal disease, malignancy and hypoparathyroidism. Ergocalciferol has been associated with gastrointestinal, neuropsychiatric and immunological effects. Hence it is recommended that ergocalciferol should only be used in a clinical setting where detailed information regarding risks and contraindication is available.

Unverified Answer
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