EUCTR2010-018285-23-GB进行中（未招募）1 期
Effect of active vitamin D treatment on arterial stiffness and albuminuria in patients with type 2 diabetes and stage 3 chronic kidney disease - Vitamin D in Diabetes Trial (VDDT)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Patients with a diagnosis of T2DM.
- •2.Patients aged between 40 and 75 years (inclusive).
- •3.Chronic Kidney disease (CKD) stage 3 [estimated glomerular filtration rate (eGFR*) 30-59 ml/min on the two most recent (within 12 months) consecutive measurements].
- •4.A history of an elevated urinary albumin excretion rate (UAER) [albumin: creatinine ratio= 2.5 mg/mmol in men and =3mg/mmol in women on more than three occasions or UAER =20mcg/min on at least two timed urine collections or two or more positive urine dipsticks results for proteinuria or two or more urine protein creatinine ratios (PCR)>15 mg/mmol] or clinical evidence of diabetic nephropathy
- •5.Normal corrected serum calcium (2.1-2.6mmol/l).
- •6.Normal phosphate (0.8-1.5 mmol/l) levels.
- •7.A raised intact parathyroid hormone (iPTH) level between 30 pg/ml and 200pg/ml at screening visit or a history of a raised intact parathyroid hormone (iPTH) level between 30 pg/ml and 200pg/ml in the 3 months preceding screening visit.
- •8.Written informed consent to participate in the study prior to any study procedures.
- •9.Ability to communicate and comply with all study requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •An iPTH =200 pg/ml at study entry (a conservative treatment threshold for initiating active vitamin D treatment for prevention of renal osteodystrophy).
- •History of non diabetic or obstructive kidney disease.
- •Poorly controlled hypertension (systolic and diastolic blood pressure >180mmHg and >110 mmHg respectively).
- •Presence of connective tissue diseases known to affect arterial vasculature.
- •Atrial fibrillation or other cardiac rhythm disorders.
- •Pregnancy or lactation.
- •History of a cardiovascular or cerebrovascular event in the preceding 6 months.
- •Patients already on vitamin D (inactive or active) treatment.
研究者
相似试验
招募中
不适用
Effect of Vitamin D supplementation on vascular functions in type 2 diabetic patients with vitamin D deficiency.CTRI/2016/03/006698JIPMER66
进行中（未招募）
不适用
The effect of vitamin D replacement on arterial stiffness in an elderly community based population.Vitamin D deficiency/insufficiencyArterial stiffnessEUCTR2010-024417-31-IEBeaumont Hospital/RCSI
尚未招募
不适用
Vitamin D supplementation in ckronic kidney diseaseCTRI/2013/05/003648Department of Biotechnology
尚未招募
不适用
To study if vitamin D supplementation in vitamin D deficient patients of rheumatoid arthritis impproves vascular function in them. Vascular function predicts risk of cardiovascular diseases in them and will be measured by flow mediated dilation of brachial artery.CTRI/2018/03/012846PGIMER Chandigarh
招募中
4 期
Effect of vitamin D replacement on functions of blood vessels in patients with vitamin D deficiency after correcting thyroid hormone deficiencyCTRI/2017/03/008267JIPMER intramural