Sarcoidosis Clinical Trial
Official title:
Vitamin D Homeostasis in Sarcoidosis
Verified date | November 2023 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 90 |
Est. completion date | December 30, 2026 |
Est. primary completion date | August 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Southwestern Medical Center, and Parkland Health and Hospital System | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Bolland MJ, Wilsher ML, Grey A, Horne AM, Fenwick S, Gamble GD, Reid IR. Randomised controlled trial of vitamin D supplementation in sarcoidosis. BMJ Open. 2013 Oct 23;3(10):e003562. doi: 10.1136/bmjopen-2013-003562. — View Citation
Capolongo G, Xu LH, Accardo M, Sanduzzi A, Stanziola AA, Colao A, Agostini C, Zacchia M, Capasso G, Adams-Huet B, Moe OW, Maalouf NM, Sakhaee K, Hsia CC. Vitamin-D status and mineral metabolism in two ethnic populations with sarcoidosis. J Investig Med. 2 — View Citation
Kamphuis LS, Bonte-Mineur F, van Laar JA, van Hagen PM, van Daele PL. Calcium and vitamin D in sarcoidosis: is supplementation safe? J Bone Miner Res. 2014 Nov;29(11):2498-503. doi: 10.1002/jbmr.2262. — View Citation
Vieth R. Why the optimal requirement for Vitamin D3 is probably much higher than what is officially recommended for adults. J Steroid Biochem Mol Biol. 2004 May;89-90(1-5):575-9. doi: 10.1016/j.jsbmb.2004.03.038. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in lung function from baseline | (Measurement at end of study)/(measurement at enrollment) | Baseline and 24 weeks | |
Secondary | 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). | Baseline, 12 and 24 weeks | |
Secondary | Change in six minute walk distance | (Measurement at end of study)/(measurement at enrollment) | Baseline and 24 weeks | |
Secondary | Change in blood cell counts from complete blood count (CBC) | (Measurement at study point)/(initial measurement at enrollment) | Baseline, 12 and 24 weeks | |
Secondary | Change in metabolic profile from complete metabolic panel (CMP) | (Measurement at study point)/(initial measurement at enrollment) | Baseline, 12 and 24 weeks | |
Secondary | Change in serum vitamin-D metabolite concentration | (Measurement at study point)/(initial measurement at enrollment) | Baseline, 12 and 24 weeks | |
Secondary | Change in serum angiotensin converting enzyme (ACE) concentration | (Measurement at study point)/(initial measurement at enrollment) | Baseline, 12 and 24 weeks | |
Secondary | Change in serum serum gamma-globulin concentration | (Measurement at study point)/(initial measurement at enrollment) | Baseline, 12 and 24 weeks | |
Secondary | Change in serum C-reactive protein (CRP) concentration | (Measurement at study point)/(initial measurement at enrollment) | Baseline, 12 and 24 weeks | |
Secondary | Change in serum tumor Necrosis factor-alpha (TNF-alpha) concentration | (Measurement at study point)/(initial measurement at enrollment) | Baseline, 12 and 24 weeks | |
Secondary | Change in serum interferon-gamma (IFN-gamma) concentration | (Measurement at study point)/(initial measurement at enrollment) | Baseline, 12 and 24 weeks | |
Secondary | Changes in serum interleukin concentration | (Measurement at study point)/(initial measurement at enrollment) | Baseline, 12 and 24 weeks | |
Secondary | Change in 24 hour urine calcium/creatinine ratio | (Measurement at study point)/(initial measurement at enrollment) | Baseline, 12 and 24 weeks | |
Secondary | Change in 24 hour urine deoxypyridinoline concentration | (Measurement at study point)/(initial measurement at enrollment) | Baseline, 12 and 24 weeks | |
Secondary | Change in fractional lung tissue volume on computed/positron emission tomography (PET/CT) | (Measurement at end of study)/(measurement at enrollment) | Baseline and 24 weeks | |
Secondary | Change in Fluoro-deoxyglucose (FDG) uptake on PET/CT | (Measurement at end of study)/(measurement at enrollment | Baseline and 24 weeks | |
Secondary | Change in bone density z-score | (Measurement at end of study)/(measurement at enrollment) | Baseline and 24 weeks |
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