Evaluating vitamin D's role in sarcoidosis
Vitamin D Homeostasis in Sarcoidosis
This study is testing if giving vitamin D to people with sarcoidosis who have low levels of it can help reduce their symptoms compared to those who get a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT03621553 on ClinicalTrials.gov |
What this trial studies
This study investigates how vitamin D levels affect the severity of sarcoidosis and the impact of vitamin D supplementation in patients who are deficient. Participants with sarcoidosis and low vitamin D will be divided into two groups: one receiving standard vitamin D supplementation and the other receiving a placebo. Additionally, patients with sufficient vitamin D levels will serve as control subjects. The study aims to clarify the relationship between vitamin D status and sarcoidosis inflammation.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with sarcoidosis who are also vitamin D insufficient.
Not a fit: Patients with active infections, other inflammatory diseases, or malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of sarcoidosis through vitamin D repletion.
How similar studies have performed: Other studies have suggested a potential link between vitamin D levels and inflammatory conditions, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Stable medical condition defined as no hospitalization or emergency room visit in the previous 3 months * No evidence of active pulmonary or systemic infection * No other active inflammatory disease, * No active malignancy. * Normal serum ionized calcium level Exclusion Criteria: * Hospitalization or emergency room visit in the previous 3 months * Evidence of active pulmonary or systemic infection * Evidence of active other inflammatory disease * Evidence of active malignancy * Elevated serum ionized calcium level
Where this trial is running
Dallas, Texas
- University of Texas Southwestern Medical Center, and Parkland Health and Hospital System — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Connie Hsia, MD — University of Texas Southwestern Medical Center
- Study coordinator: Connie Hsia, MD
- Email: Connie.Hsia@utsouthwestern.edu
- Phone: 2146483426
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.