Actively Recruiting

Phase 4
Age: 21Years +
All Genders
ID03621553

Vitamin D Homeostasis in Sarcoidosis Evaluating Vitamin D Supplementation Effects on Sarcoidosis Severity

Led by University of Texas Southwestern Medical Center · Updated on 2026-01-02

90

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying sarcoidosis, a disease causing inflammation in multiple organs, to understand how vitamin D levels affect the severity of this condition. The research aims to explore if restoring vitamin D in patients with low levels can reduce inflammation and improve symptoms. This Phase 4 trial also examines the unique way sarcoidosis affects vitamin D metabolism and immune response. Participants with low vitamin D will be randomly assigned to receive either vitamin D2 (ergocalciferol) supplements or placebo capsules, both given orally once a week for 12 weeks, then once a month for another 12 weeks. All participants will take daily calcium citrate with vitamin D2 tablets for 24 weeks. Those with normal vitamin D levels will be monitored as controls. The study uses a triple-blind design to reduce bias. During the 24-week study, participants will undergo lung function tests and complete questionnaires at baseline, 12 weeks, and 24 weeks. Researchers will also monitor walking ability, blood tests, metabolic profiles, vitamin D and inflammation markers, and imaging scans including PET/CT. Bone density will be checked at the start and end. These assessments will help measure changes and safety throughout the trial, which concludes with a final evaluation of lung function.

CONDITIONS

Brief Title

Vitamin D Homeostasis in Sarcoidosis

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 21 years or older
  • Stable medical condition with 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 24 weeks

Participants receive vitamin D2 or placebo once a week for 12 weeks, then once a month for 12 weeks. Daily dietary calcium citrate with vitamin D2 is taken for 24 weeks.

Visits at baseline, 12 weeks, and 24 weeks for assessments

Trial Site Locations

Total: 1 location

1

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

Dallas, Texas, United States, 75390-9034

Actively Recruiting

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Research Team

C

Connie Hsia, MD

K

Khashayar Sakhaee, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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