Vitamin D Homeostasis in Sarcoidosis

• Register: ClinicalTrials.gov
• Last refreshed on: 20 November 2023
• Main ID: NCT03621553
• Date of registration: 17/07/2018
• Prospective Registration: No
• Primary sponsor: University of Texas Southwestern Medical Center
• Public title: Vitamin D Homeostasis in Sarcoidosis
• Scientific title: Vitamin D Homeostasis in Sarcoidosis
• Date of first enrolment: July 1, 2010
• Target sample size: 90
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03621553
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Connie Hsia, MD
• Affiliation: University of Texas Southwestern Medical Center

Key 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



Age minimum: 21 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Sarcoidosis

Vitamin D Insufficiency

Intervention(s)

Drug: Placebo

Drug: Calcium Citrate with Vitamin D2

Drug: Ergocalciferol

Primary Outcome(s)

Change in lung function from baseline [Time Frame: Baseline and 24 weeks]

Secondary Outcome(s)

Change in King's Sarcoidosis Questionnaire Score [Time Frame: Baseline, 12 and 24 weeks]

Change in serum tumor Necrosis factor-alpha (TNF-alpha) concentration [Time Frame: Baseline, 12 and 24 weeks]

Change in serum vitamin-D metabolite concentration [Time Frame: Baseline, 12 and 24 weeks]

Change in 24 hour urine calcium/creatinine ratio [Time Frame: Baseline, 12 and 24 weeks]

Change in serum angiotensin converting enzyme (ACE) concentration [Time Frame: Baseline, 12 and 24 weeks]

Change in 24 hour urine deoxypyridinoline concentration [Time Frame: Baseline, 12 and 24 weeks]

Change in blood cell counts from complete blood count (CBC) [Time Frame: Baseline, 12 and 24 weeks]

Change in metabolic profile from complete metabolic panel (CMP) [Time Frame: Baseline, 12 and 24 weeks]

Change in serum interferon-gamma (IFN-gamma) concentration [Time Frame: Baseline, 12 and 24 weeks]

Change in serum serum gamma-globulin concentration [Time Frame: Baseline, 12 and 24 weeks]

Change in six minute walk distance [Time Frame: Baseline and 24 weeks]

Change in serum C-reactive protein (CRP) concentration [Time Frame: Baseline, 12 and 24 weeks]

Change in Fluoro-deoxyglucose (FDG) uptake on PET/CT [Time Frame: Baseline and 24 weeks]

Changes in serum interleukin concentration [Time Frame: Baseline, 12 and 24 weeks]

Change in bone density z-score [Time Frame: Baseline and 24 weeks]

Change in fractional lung tissue volume on computed/positron emission tomography (PET/CT) [Time Frame: Baseline and 24 weeks]

Secondary ID(s)

STU 062010-055

Source(s) of Monetary Support

Please refer to primary and secondary sponsors