Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low vit-D, Ergocalciferol | Experimental | Low serum vitamin D level, split by use or non-use of systemic corticosteroid. Vitamin D2 (Ergocalciferol) 50,000 units will be given by mouth once a week for 12 weeks, then once a month for 12 weeks. Daily dietary requirement (calcium citrate with vitamin D2 (200 mg/250 Units tablets, 4 tablets per day) will be given by mouth for 24 weeks). |
|
| Low vit-D, Placebo | Placebo Comparator | Low serum vitamin D level, split by use or non-use of systemic corticosteroid. Placebo capsules of identical size and appearance will be given by mouth once a week for 12 weeks, then once a month for 12 weeks. Daily dietary requirement (calcium citrate with vitamin D2 (200 mg/250 Units tablets, 4 tablets per day) will be given by mouth for 24 weeks). |
|
| Normal vit-D, control | Other | Normal serum vitamin D level, split by use or non-use of systemic corticosteroid. Daily dietary requirement (calcium citrate with vitamin D2 (200 mg/250 Units tablets, 4 tablets per day) will be given by mouth for 24 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ergocalciferol | Drug | Vitamin D2 50,000 units |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in lung function from baseline | (Measurement at end of study)/(measurement at enrollment) | Baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Connie Hsia, MD | Contact | 2146483426 | Connie.Hsia@utsouthwestern.edu | |
| Khashayar Sakhaee, MD | Contact | 2146480324 | Khashayar.Sakhaee@utsouthwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Connie Hsia, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center, and Parkland Health and Hospital System | Recruiting | Dallas | Texas | 75390-9034 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27053725 | Result | 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. 2016 Jun;64(5):1025-34. doi: 10.1136/jim-2016-000101. Epub 2016 Apr 6. | |
| 15225842 |
Not provided
Not provided
De-identified participant data for primary and secondary outcome measures will be made available.
Within 6 months of study completion
Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement.
Not provided
Not provided
| ID | Term |
|---|---|
| D012507 | Sarcoidosis |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
Not provided
Not provided
| ID | Term |
|---|---|
| D004872 | Ergocalciferols |
| D019355 | Calcium Citrate |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Vitamin-D insufficient subjects will receive either vitamin D2 repletion or placebo Vitamin-D sufficient subjects will be observed without treatment.
Not provided
Not provided
Groups separated by a) use / non-use of oral prednisone, and b) status of serum 25-hydroxy-vitamin-D level (sufficient or insufficient). Those who are vitamin-D insufficient will be randomized to receive either vitamin D2 or placebo.
| Placebo | Drug | Sugar pill manufactured to mimic ergocalciferol 50,000 units |
|
|
| Calcium Citrate with Vitamin D2 | Drug | To meet the recommended minimum daily dietary requirements |
|
|
| Baseline, 12 and 24 weeks |
| Change in six minute walk distance | (Measurement at end of study)/(measurement at enrollment) | Baseline and 24 weeks |
| Change in blood cell counts from complete blood count (CBC) | (Measurement at study point)/(initial measurement at enrollment) | Baseline, 12 and 24 weeks |
| Change in metabolic profile from complete metabolic panel (CMP) | (Measurement at study point)/(initial measurement at enrollment) | Baseline, 12 and 24 weeks |
| Change in serum vitamin-D metabolite concentration | (Measurement at study point)/(initial measurement at enrollment) | Baseline, 12 and 24 weeks |
| Change in serum angiotensin converting enzyme (ACE) concentration | (Measurement at study point)/(initial measurement at enrollment) | Baseline, 12 and 24 weeks |
| Change in serum serum gamma-globulin concentration | (Measurement at study point)/(initial measurement at enrollment) | Baseline, 12 and 24 weeks |
| Change in serum C-reactive protein (CRP) concentration | (Measurement at study point)/(initial measurement at enrollment) | Baseline, 12 and 24 weeks |
| Change in serum tumor Necrosis factor-alpha (TNF-alpha) concentration | (Measurement at study point)/(initial measurement at enrollment) | Baseline, 12 and 24 weeks |
| Change in serum interferon-gamma (IFN-gamma) concentration | (Measurement at study point)/(initial measurement at enrollment) | Baseline, 12 and 24 weeks |
| Changes in serum interleukin concentration | (Measurement at study point)/(initial measurement at enrollment) | Baseline, 12 and 24 weeks |
| Change in 24 hour urine calcium/creatinine ratio | (Measurement at study point)/(initial measurement at enrollment) | Baseline, 12 and 24 weeks |
| Change in 24 hour urine deoxypyridinoline concentration | (Measurement at study point)/(initial measurement at enrollment) | Baseline, 12 and 24 weeks |
| 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 |
| Change in Fluoro-deoxyglucose (FDG) uptake on PET/CT | (Measurement at end of study)/(measurement at enrollment | Baseline and 24 weeks |
| Change in bone density z-score | (Measurement at end of study)/(measurement at enrollment) | Baseline and 24 weeks |
| 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. |
| 24157819 | Result | 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. |
| 24753153 | Result | 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. |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D019343 | Citric Acid |
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |