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NCT03032328 · ClinicalTrials.gov registry record · NA
Vitamin D Deficiency and Dysautonomia
A NA study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 31
- Enrollment target
NCT03032328 is a NA study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 31 participants.
The verdict
NCT03032328, a NA study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
Study 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.
Interventions
- DIETARY_SUPPLEMENT vitamin D supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2016-06 |
| Est. Completion | 2022-12-21 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03032328
The ClinicalTrials.gov registry entry for NCT03032328 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which vitamin D supplement is the first listed.
NCT03032328 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03032328 about?
NCT03032328 is a clinical study titled "Vitamin D Deficiency and Dysautonomia". 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 def...
What is the current status of trial NCT03032328?
This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2016-06. Estimated completion is 2022-12-21.
What interventions are being tested in trial NCT03032328?
The interventions under investigation include: vitamin D supplement (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03032328?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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