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Vitamin Supplement

Vitamin D for Sarcoidosis

Phase 4

Recruiting

Led By Connie Hsia, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No evidence of active pulmonary or systemic infection

Stable medical condition defined as no hospitalization or emergency room visit in the previous 3 months

Must not have

Evidence of active pulmonary or systemic infection

Hospitalization or emergency room visit in the previous 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 and 24 weeks

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing whether vitamin D can help treat sarcoidosis, a disease where inflammation occurs throughout the body.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Possible side effects include high calcium levels leading to kidney stones or confusion, digestive issues like stomach pain or constipation, and rare cases of allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I do not have any active cancer.

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I do not have any active inflammatory diseases.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have an active inflammatory condition.

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I currently have active cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 and 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 and 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in lung function from baseline

Secondary study objectives

Change in 24 hour urine calcium/creatinine ratio

Change in 24 hour urine deoxypyridinoline concentration

Body Weight Changes

+13 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ergocalciferol

2008

Completed Phase 4

~810

0 / 8Eligibility criteria met