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Vitamin D Deficiency and Dysautonomia

Primary Purpose

Vitamin D Deficiency, Orthostatic Intolerance, Nausea

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

vitamin D supplement

About this trial

This is an interventional treatment trial for Vitamin D Deficiency

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Wake Forest Baptist Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

vitamin D supplement

Arm Description

patient's will be given a vitamin D

Outcomes

Primary Outcome Measures

Improvement of orthostatic intolerance symptoms usint tilt table test

assessment of orthostatic intolerance will be done using tilt table test

Secondary Outcome Measures

improvement of nausea symptoms

assessment of nausea symptoms will be done using nausea questionaire

Full Information

NCT ID

NCT03032328

First Posted

November 22, 2016

Last Updated

January 25, 2023

Sponsor

Wake Forest University Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03032328

Brief Title

Vitamin D Deficiency and Dysautonomia

Official Title

Comprehensive Assessment of Vascular and Autonomic Function in Children With Low Vitamin D

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

June 2016 (Actual)

Primary Completion Date

December 21, 2022 (Actual)

Study Completion Date

December 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency, Orthostatic Intolerance, Nausea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

vitamin D supplement

Arm Type

Experimental

Arm Description

patient's will be given a vitamin D

Intervention Type

Dietary Supplement

Intervention Name(s)

vitamin D supplement

Intervention Description

Patients will be given a dose of vitamin D for at least 2 months

Primary Outcome Measure Information:

Title

Improvement of orthostatic intolerance symptoms usint tilt table test

Description

assessment of orthostatic intolerance will be done using tilt table test

Time Frame

2 months

Secondary Outcome Measure Information:

Title

improvement of nausea symptoms

Description

assessment of nausea symptoms will be done using nausea questionaire

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hossam Shaltout, PhD

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest Baptist Health

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Vitamin D Deficiency and Dysautonomia

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