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Vitamin Supplement

Vitamin D for Sarcoidosis

Phase 4

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 and 24 weeks

Awards & highlights

Study 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.Check my eligibility

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).See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in lung function from baseline

Secondary outcome measures

Change in 24 hour urine calcium/creatinine ratio

Change in 24 hour urine deoxypyridinoline concentration

Body Weight Changes

+13 more

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,709 Total Patients Enrolled

1 Trials studying Sarcoidosis

128 Patients Enrolled for Sarcoidosis

Connie Hsia, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center

Media Library

Ergocalciferol (Vitamin Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03621553 — Phase 4

Sarcoidosis Research Study Groups: Normal vit-D, control, Low vit-D, Ergocalciferol, Low vit-D, Placebo

Sarcoidosis Clinical Trial 2023: Ergocalciferol Highlights & Side Effects. Trial Name: NCT03621553 — Phase 4

Ergocalciferol (Vitamin Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03621553 — Phase 4

Frequently Asked Questions

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

What is the current enrollment rate of patients in this investigation?

"At present, this medical study is not seeking patients. It was initially published on July 1st 2010 and the most recent edit was made on May 31st 2022. If you are searching for other trials, there are 34 studies admitting participants with sarcoidosis and 4 clinical trials researching Calcium Citrate combined with Vitamin D2 that are actively recruiting."

Answered by AI

Has the Food and Drug Administration verified Calcium Citrate in conjunction with Vitamin D2?

"The safety of Calcium Citrate with Vitamin D2 is rated a 3 as it has been approved by the FDA, signifying that this is at least Phase 4 of clinical testing."

Answered by AI

Are there any antecedent trials regarding the combination of Calcium Citrate and Vitamin D2?

"Currently, there are 4 clinical trials in process for Calcium Citrate with Vitamin D2 and none of them have reached Phase 3. Dallas, Texas is the primary location conducting such research but other centres across America are also participating in this study."

Answered by AI

Is enrollment in this trial still available to qualified participants?

"This study is not currently seeking patients, with the original posting on July 1st 2010 and last update occurring on May 31st 2022. If you're searching for other trials related to sarcoidosis, there are presently 34 clinical studies in progress while 4 are focusing specifically on Calcium Citrate with Vitamin D2."

Answered by AI

What medical conditions typically necessitate the prescription of Calcium Citrate with Vitamin D2?

"Calcium Citrate with Vitamin D2 is commonly used for managing hypoparathyroidism. Additionally, it may be prescribed as a dietary supplement to treat deficiencies and address issues like vitamin d deficiency and phosphaturia."

Answered by AI