NCT03621553 Vitamin D Homeostasis in Sarcoidosis
| NCT ID | NCT03621553 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Sarcoidosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2010-07-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 90 participants in total. It began in 2010-07-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Connie Hsia, MD
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT03621553 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Sarcoidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03621553 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03621553 currently recruiting?
Yes, NCT03621553 is actively recruiting participants. Contact the research team at Connie.Hsia@utsouthwestern.edu for enrollment information.
Where is the NCT03621553 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT03621553 clinical trial?
NCT03621553 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Connie Hsia, MD at University of Texas Southwestern Medical Center. The trial plans to enroll 90 participants.