Vitamin D Homeostasis in Sarcoidosis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in lung function from baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Low vit-D, Ergocalciferol
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).
干预措施: Ergocalciferol (Drug)
Low vit-D, Ergocalciferol
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).
干预措施: Calcium Citrate with Vitamin D2 (Drug)
Low vit-D, Placebo
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).
干预措施: Calcium Citrate with Vitamin D2 (Drug)
Normal vit-D, control
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).
干预措施: Calcium Citrate with Vitamin D2 (Drug)
Low vit-D, Placebo
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).
干预措施: Placebo (Drug)
结局指标
主要结局
Change in lung function from baseline
时间窗: Baseline and 24 weeks
(Measurement at end of study)/(measurement at enrollment)
次要结局
- Changes in serum interleukin concentration(Baseline, 12 and 24 weeks)
- Change in 24 hour urine deoxypyridinoline concentration(Baseline, 12 and 24 weeks)
- Change in blood cell counts from complete blood count (CBC)(Baseline, 12 and 24 weeks)
- Change in six minute walk distance(Baseline and 24 weeks)
- Change in metabolic profile from complete metabolic panel (CMP)(Baseline, 12 and 24 weeks)
- Change in serum vitamin-D metabolite concentration(Baseline, 12 and 24 weeks)
- Change in serum angiotensin converting enzyme (ACE) concentration(Baseline, 12 and 24 weeks)
- Change in serum serum gamma-globulin concentration(Baseline, 12 and 24 weeks)
- Change in King's Sarcoidosis Questionnaire Score(Baseline, 12 and 24 weeks)
- Change in serum C-reactive protein (CRP) concentration(Baseline, 12 and 24 weeks)
- Change in 24 hour urine calcium/creatinine ratio(Baseline, 12 and 24 weeks)
- Change in bone density z-score(Baseline and 24 weeks)
- Change in serum tumor Necrosis factor-alpha (TNF-alpha) concentration(Baseline, 12 and 24 weeks)
- Change in serum interferon-gamma (IFN-gamma) concentration(Baseline, 12 and 24 weeks)
- Change in fractional lung tissue volume on computed/positron emission tomography (PET/CT)(Baseline and 24 weeks)
- Change in Fluoro-deoxyglucose (FDG) uptake on PET/CT(Baseline and 24 weeks)
研究者
Connie C W Hsia
Professor of Internal Medicine
University of Texas Southwestern Medical Center