Vitamin-D status and mineral metabolism in two ethnic populations with sarcoidosis.
Giovanna Capolongo, Li Hao Richie Xu, Mariasofia Accardo...
https://pubmed.ncbi.nlm.nih.gov/27053725Actively Recruiting
Led by University of Texas Southwestern Medical Center · Updated on 2026-01-02
90
Participants Needed
1
Research Sites
47 weeks
Total Duration
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
Vitamin D Homeostasis in Sarcoidosis
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Total: 1 location
1
University of Texas Southwestern Medical Center, and Parkland Health and Hospital System
Dallas, Texas, United States, 75390-9034
Actively Recruiting
C
Connie Hsia, MD
K
Khashayar Sakhaee, MD
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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