University of Texas Southwestern Medical Center, and Parkland Health and Hospital System
Dallas, Texas, 75390-9034, United States
Location status: Recruiting
NCT Number: NCT03621553
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.
Interested in participating?
Request Info21 year and older
All sexes
Interventional
Phase 4
Dallas, Texas, 75390-9034, United States
Location status: Recruiting
Sarcoidosis is a multi-system inflammatory disease characterized by T-helper lymphocyte hyperactivity leading to granulomatous inflammation. The granuloma cells autonomously convert 25-hydroxy-vitamin-D (25OHD) to the active metabolite 1,25-dihydroxy-vitamin-D (1,25OH2D) independent of normal feedback control but dependent on substrate (25OHD) concentration.
Circulating 1,25OH2D exerts both anti-inflammatory and mineral metabolic actions. Deficiency of 25OHD limits substrate-dependent 1,25OH2D synthesis, diminishes anti-antigenic innate immunity and augments pro-inflammatory adaptive immunity. Thus, low vitamin-D stores could aggravate sarcoid inflammation while repletion of vitamin-D stores could mitigate inflammation in sarcoidosis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Vitamin D2 50,000 units
Other names: Vitamin D2
Sugar pill manufactured to mimic ergocalciferol 50,000 units
Other names: Placebo oral tablets
To meet the recommended minimum daily dietary requirements
Other names: Citracal
Time frame: Baseline and 24 weeks
(Measurement at end of study)/(measurement at enrollment)
Time frame: Baseline, 12 and 24 weeks
Standard validated questionnaire for assessing the impact of sarcoidosis on quality of life. Questions address symptoms, activities and psychosocial impacts of disease. It consists of 29 questions on general health, medications, and symptoms in lung, skin, and eyes, summed to derive a total score. Each question is scored on a scale of 1 (worst) to 7 (best). Minimum total score = 5 (poorest health). Maximum total score = 203 (best health).
Time frame: Baseline and 24 weeks
(Measurement at end of study)/(measurement at enrollment)
Time frame: Baseline, 12 and 24 weeks
(Measurement at study point)/(initial measurement at enrollment)
Time frame: Baseline, 12 and 24 weeks
(Measurement at study point)/(initial measurement at enrollment)
Time frame: Baseline, 12 and 24 weeks
(Measurement at study point)/(initial measurement at enrollment)
Time frame: Baseline, 12 and 24 weeks
(Measurement at study point)/(initial measurement at enrollment)
Time frame: Baseline, 12 and 24 weeks
(Measurement at study point)/(initial measurement at enrollment)
Time frame: Baseline, 12 and 24 weeks
(Measurement at study point)/(initial measurement at enrollment)
Time frame: Baseline, 12 and 24 weeks
(Measurement at study point)/(initial measurement at enrollment)
Time frame: Baseline, 12 and 24 weeks
(Measurement at study point)/(initial measurement at enrollment)
Time frame: Baseline, 12 and 24 weeks
(Measurement at study point)/(initial measurement at enrollment)
Time frame: Baseline, 12 and 24 weeks
(Measurement at study point)/(initial measurement at enrollment)
Time frame: Baseline, 12 and 24 weeks
(Measurement at study point)/(initial measurement at enrollment)
Time frame: Baseline and 24 weeks
(Measurement at end of study)/(measurement at enrollment)
Time frame: Baseline and 24 weeks
(Measurement at end of study)/(measurement at enrollment
Time frame: Baseline and 24 weeks
(Measurement at end of study)/(measurement at enrollment)
Interested in participating?
Request InfoUniversity of Texas Southwestern Medical Center
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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