The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Effect of Vitamin D Supplementation on Albuminuria in CKD Patients as Assessed by Urine Albumin/Creatinine Measures.
研究概览
简要总结
A randomized clinical trial to determine if vitamin D repletion in CKD (Chronic Kidney Disease) patients with low vitamin D levels will decrease proteinuria, a marker of kidney damage.
详细描述
This RCT will enroll 74 subjects, men and women over age of 18, with stage 3-4 CKD from various causes including diabetes and hypertension. Patients will be recruited from the Montefiore Medical Center Nephrology clinics and the Montefiore Medical Center internal medicine clinics and other interested individuals.
Informed consent will be obtained on all subjects. All subjects with meet with one of the investigators who will verbally explain to them the purpose of the study and the alternatives.
Blood and urine tests will be collected to assess for proteinuria, vitamin D levels, serum creatinine, calcium and phosphorus, as well as a urine albumin, calcium and creatinine. These tests will be used for experimental purposes only and will be collected at each study visit over the span of 6 months.
There will be two arms, an arm randomized to 50000IU of ergocalciferol once weekly and a placebo arm for 3 months. For an additional 3 months, all patients will be repleted with Vitamin D via open-label extension, based on their levels after 3 months.
Secondary outcomes include ambulatory blood pressure monitoring, hemoglobin A1c, HOMA-IR.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Ability to provide informed consent
- •Chronic kidney disease stage 3 and 4
- •On ACE inhibitor or ARB for albuminuria if tolerated
- •Assessed during eligibility screen:
- •Albuminuria >30 mg/g creatinine
- •25(OH) vitamin D level >12.5 and <75 nmol/L
排除标准
- •On vitamin D in past 4 weeks
- •Plans to relocate out of New York City in the next 6 months
- •25 (OH) Vitamin D level <12.5 nmol/L
- •HIV infection
- •History of hypercalcemia or kidney stones
- •Serum phosphate >5.5 mg/dl in past 3 months
- •Serum calcium >10.0 mg/dl in past 3 months
- •SBP >160 DBP >100 at screening visit
- •Transplanted organ
- •Polycystic kidney disease
- •Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months
研究组 & 干预措施
Vitamin D 50000 IU
Patients randomized to this arm will receive 50,000 IU of ergocalciferol in one unmarked pill once weekly.
干预措施: Vitamin D (Drug)
Placebo
Patients randomized to this arm will receive a placebo pill once weekly.
干预措施: Placebo (Other)
结局指标
主要结局
Effect of Vitamin D Supplementation on Albuminuria in CKD Patients as Assessed by Urine Albumin/Creatinine Measures.
时间窗: 3 months
Urine albumin and creatinine were measured on spot urine specimens.
次要结局
- Effect of Repletion Doses of Vitamin D Increase 25(OH) Vitamin D Levels to Above 30 ng/mL in a Multi-ethnic Sample of Patients With CKD as a Secondary Outcome.(3 months)
- Effect of Vitamin D Supplementation on Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure in CKD Patients as a Secondary Outcome.(3 months)