ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitamin D Deficiency and Dysautonomia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03032328
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
In previous work the investigator identified a group of children between the ages of 10-18 years whose diagnostic workup for chronic nausea unexplained by conventional diagnostic tests has unexpectedly revealed underlying cardiovascular instability manifesting as orthostatic intolerance, primary defined as postural orthostatic tachycardia syndrome (POTS) (88%). While this is an atypical initial presentation for orthostatic intolerance in general, the investigator believes that the cardiovascular problem is serious and represents a cause of the nausea in a majority of these individuals, as treatment of the POTS with fludrocortisone reduced the symptoms of nausea. While fludrocortisone treatment abrogates the fall in baroreflex sensitivity (BRS) during tilt in part, it did not completely correct the tachycardia symptoms or the BRS suppression during HUT. Furthermore it caused an elevation in MAP in supine position, which may lead to future cardiovascular problems such as early onset hypertension and cardiac hypertrophy. This argues for a different treatment approach. The investigator presents preliminary data in this application revealing that OI subjects tend to have lower 25-hydroxy vitamin D (25(OH)D) compared to non OI subjects.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Orthostatic Intolerance Nausea Dietary Supplement: vitamin D supplement Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comprehensive Assessment of Vascular and Autonomic Function in Children With Low Vitamin D
Actual Study Start Date : June 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
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 2 months




Primary Outcome Measures :
  1. Improvement of orthostatic intolerance symptoms usint tilt table test [ Time Frame: 2 months ]
    assessment of orthostatic intolerance will be done using tilt table test


Secondary Outcome Measures :
  1. improvement of nausea symptoms [ Time Frame: 2 months ]
    assessment of nausea symptoms will be done using nausea questionaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032328


Contacts
Contact: Anya Brown (336) 716-4325 anybrown@wakehealth.edu
Contact: Hossam Shaltout, PhD

Locations
United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Anya Brown    336-716-4325    anybrown@wakehealth.edu   
Contact: Hossam Shaltout, PhD         
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Hossam Shaltout, PhD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03032328     History of Changes
Other Study ID Numbers: IRB00036629
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Primary Dysautonomias
Autonomic Nervous System Diseases
Vitamin D Deficiency
Orthostatic Intolerance
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents