Vitamin D Deficiency and Dysautonomia
关键词
抽象
描述
The investigators approach will combine HUT testing coupled with autonomic testing that includes continuous blood pressure and HR measurements, Baroreflex Sensitivity and Hear Rate Variability, to establish objective autonomic profiles, along with vascular testing including Pulse Wave Velocity, Ankle Brachial Index at rest and measures of blood volume of different compartments, Systemic Vascular Resistance and cardiac output at rest and in response to hand-grip stress. This will allow the treating physician to provide patients with a specific diagnosis, and ultimately develop data for more focused, rational treatments than currently achieved. The full vascular profile is also novel and has the potential to improve therapeutic management of the participants independent of the outcomes with the vitamin D supplementation. This study is designed to recruit 80 participants into 4 groups of 20 each. The 4 groups represent non OI (those recruited from the clinics for nausea but without a positive tilt test) or those showing orthostatic intolerance (POTS alone, OH, and syncope). The general objective of this proposal is to address this gap in knowledge by determining vascular function, the neurohumoral profile and autonomic status supine and in response to HUT in OI subjects with low vitamin D levels in comparison with subjects who test negative for OI on the HUT.
The investigators aim to examine the effect of vitamin D replacement on these measures, providing the possibility of therapeutic use of vitamin D to treat or ameliorate the symptoms associated with OI.
日期
| 最后验证: | 05/31/2020 |
| 首次提交: | 11/21/2016 |
| 提交的预估入学人数: | 01/24/2017 |
| 首次发布: | 01/25/2017 |
| 上次提交的更新: | 06/22/2020 |
| 最近更新发布: | 06/23/2020 |
| 实际学习开始日期: | 05/31/2016 |
| 预计主要完成日期: | 05/31/2021 |
| 预计完成日期: | 05/31/2021 |
状况或疾病
干预/治疗
Dietary Supplement: vitamin D supplement
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: vitamin D supplement patient's will be given a vitamin D | Dietary Supplement: vitamin D supplement Patients will be given a dose of vitamin D for at least 2 months |
资格标准
| 有资格学习的年龄 | 10 Years 至 10 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - The age range of 10-18 years was chosen as we anticipate these patients will be capable of adequately answering nausea symptom questionnaires and cooperating during autonomic and tilt table testing - Patients will be recruited from the pediatric GI clinic if they meet Rome III criteria for childhood functional dyspepsia with nausea as the predominant symptom which includes: persistent or recurrent pain or discomfort (including nausea) in the upper abdomen not relieved with defecation and not associated an inflammatory, anatomic, metabolic, or neoplastic process - Patients will be recruited from the pediatric cardiology clinic for presenting symptoms of unexplained syncope not associated with cardiac anatomic anomalies or other identified cardiac pathology Exclusion Criteria: - Patients will be excluded if a metabolic, mechanical, or mucosal inflammatory cause has been defined to explain their gastrointestinal symptoms. This would include, for example, a diagnosis of inflammatory bowel disease, celiac disease, liver or pancreatic disease, hiatal hernia, or bowel obstruction - Patients with significant cardiac or cardiovascular disease, malignancy, or other comorbid conditions precluding successful completion of a 45 minute tilt test will be excluded. - Subjects who are incapable or unwilling to discontinue medications affecting autonomic function will be excluded. - Patients with diabetes will be excluded due to the possibility that the autonomic dysfunction results from a peripheral neuropathy. (We have successfully recruited these numbers of subjects in less than 2 years in a previous study of similar design - Patients who are pregnant |
结果
主要结果指标
1. Improvement of orthostatic intolerance symptoms usint tilt table test [2 months]
次要成果指标
1. improvement of nausea symptoms [2 months]
