Vitamin D Homeostasis in Sarcoidosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Texas Southwestern Medical Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Ergocalciferol
DrugVitamin D2 50,000 units
Placebo
DrugSugar pill manufactured to mimic ergocalciferol 50,000 units
Calcium Citrate with Vitamin D2
DrugTo meet the recommended minimum daily dietary requirements
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Low vit-D, ErgocalciferolExperimental treatment 2 interventions
Group B: Low vit-D, PlaceboPlacebo comparator 2 interventions
Group C: Normal vit-D, controlOther 1 intervention
Trial outcomes
Primary outcomes
1
Change in lung function from baseline
(Measurement at end of study)/(measurement at enrollment)
Time frame
Baseline and 24 weeksSecondary outcomes
1
Change in King's Sarcoidosis Questionnaire Score
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, 12 and 24 weeks2
Change in six minute walk distance
(Measurement at end of study)/(measurement at enrollment)
Time frame
Baseline and 24 weeks3
Change in blood cell counts from complete blood count (CBC)
(Measurement at study point)/(initial measurement at enrollment)
Time frame
Baseline, 12 and 24 weeks4
Change in metabolic profile from complete metabolic panel (CMP)
(Measurement at study point)/(initial measurement at enrollment)
Time frame
Baseline, 12 and 24 weeksSponsors and contacts
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Source ClinicalTrials.gov