Effect of Vitamin D Supplementation in Patients With Heart Failure and Vitamin D Deficiency
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from baseline in myocardial function and structure at 12 months
研究概览
简要总结
The purpose of this study is to determine the effects of vitamin D supplementation in patients with heart failure and vitamin D deficiency on ventricular function, inflammatory cytokines, brain natriuretic peptide, lipid profile, glucose, serum insulin, serum parathyroid hormone and calcium.
详细描述
The protocol will be held in three different Hospitals from Monterrey. Those patients with heart failure will be invited to participate; serum vitamin D will be measured, and those with vitamin D deficiency will be participating, once they meet all the inclusion criteria and none of the exclusion criteria, and sign an informed consent.
Patients will be assigned to the intervention group or placebo group according to their characteristics so that both groups are equally balanced in proportion to similar characteristics and number to guarantee homogeneity in both groups at baseline.
The study will have a 12-month time frame for each patient. Patients can be enrolled at different times.
All patients will undergo:
- A baseline measurement of vitamin D concentration in plasma and then every three months (according to season changes) for a total of five measurements.
- Myocardial function and structure measured by magnetic resonance with contrast media at baseline and end of intervention.
- Heart failure clinical follow-up with a 6 minute walk test, arterial pressure and clinical parameters every month.
- A baseline measurement of serum BNP and then every three months (5 in total).
- Serum lipid profile, glucose and insulin measurements at baseline, intermediate and at the end of the intervention.
- Anthropometric measurements (weight, body mass index, waist circumference, body fat percentage) every month.
- A baseline measurement of inflammatory cytokines in serum and then every three months (5 in total).
- Serum PTH and calcium measured at baseline and end of intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with heart failure with:
- •Ventricular ejection fraction of <40%
- •B natriuretic peptide > 300 milligrams per milliliter
- •Pharmacologic therapy with angiotensin converting enzyme inhibitors (ACEI) and beta blockers (BB)
- •NYHA class III or IV
- •Vitamin D insufficiency (less than 30 ng/ml)
排除标准
- •Subjects without hear failure diagnosis
- •Subjects with ventricular ejection fraction above 40%
- •Subjects with BNP <300 mg/ml
- •Subjects who don't take ACEI or BB
- •Subjects with NYHA class I or II
- •Subjects with serum vitamin D of ≥ 30 ng/ml
- •Subjects with metallic implants (due to magnetic resonance)
- •Subjects allergic to contrast media (gadolinium) used for magnetic resonance
- •Subjects with renal failure due to failure to eliminate contrast media
- •Suspension Criteria:
- •From intervention group: subjects who stop taking the supplement or take a different dosage than recommended for more than 80% of the time frame
- •Both groups: subjects who stop attending their monthly clinical evaluation with a cardiologist
- •Subjects who don't show up for their evaluation dates given for anthropometric measurements and laboratory sample taking
- •Subjects who don't show up their final magnetic resonance evaluation
- •Subjects having adverse symptoms to vitamin D supplementation; those suspected to have an overdose reaction
- •Subjects having an allergic reaction to magnetic resonance contrast media (gadolinium) during the magnetic resonance image taking
研究组 & 干预措施
Control Group (Placebo)
Participants in this group will receive a placebo containing gelatin and corn oil per day for 12 months
干预措施: Control group (Placebo) (Other)
Vitamin D Supplementation
Participants in this group will receive vitamin D supplements of 5 000 International units per day for 12 months.
干预措施: Vitamin D Supplementation (Other)
结局指标
主要结局
Change from baseline in myocardial function and structure at 12 months
时间窗: 12 months
Myocardial structure and function will be evaluated using magnetic resonance imaging technique. Statistical results for each variable will be reported as a mean ± standard deviation.
次要结局
- Change from baseline in inflammatory cytokines at 12 months(12 months)
- Change from baseline in serum lipid profile at 12 months(12 months)
- Change from baseline in serum calcium at 12 months(12 months)
- Change from baseline in serum parathyroid hormone at 12 months(12 months)
- Change from baseline in serum glucose at 12 months(12 months)
- Change from baseline in serum insulin at 12 months(12 months)
- Change from baseline in 6-minute walk test at 12 months(12 months)
- Change from baseline in serum vitamin D level at 12 months(12 months)
- Change from baseline in systolic blood pressure at 12 months(12 months)
- Change from baseline in diastolic blood pressure at 12 months(12 months)
- Change from baseline in serum natriuretic peptide at 12 months(12 months)
研究者
Leticia Elizondo-Montemayor
Dean of the Clinical Nutrition and Obesity Research Center. School of Medicine and Health Sciences. TEC Salud. Tecnológico de Monterrey
Instituto Tecnologico y de Estudios Superiores de Monterey