Vitamin Deficiency and Blood Pressure in Hospitalized Jewish General Hospital (JGH) Patients

Study Overview
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Brief Summary
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There is suggestive evidence that vitamin C and vitamin D deficiency may increase blood pressure across the range of blood pressures from normal to elevated. Information about this relationship is inadequate in part because of the rarity of individuals with subclinical vitamin C and D deficiency. The investigators have observed subnormal to deficient plasma vitamin C and 25-hydroxyvitamin D levels in a large proportion of patients under active treatment in the investigators' hospital. The clinical implications of widespread hypovitaminosis C and D are unknown. In this randomized prospective comparison trial the investigators will measure vitamin levels and blood pressure in clinically stable acutely hospitalized patients with a wide range of diagnoses, and expected to remain in the hospital for at least 7 more days. The investigators will examine for an inverse relationship between baseline vitamin level and blood pressure across the range of blood pressures. Consenting patients will be randomized to receive vitamin C (500 mg twice daily) or vitamin D (1000 IU twice daily) for as long as 10 days. Blood pressure will be re-measured every 2 days and vitamin levels re-measured on the last study day. Treatment courses of at least 5 days will be considered sufficient for analysis. The hypothesis is that either treatment will reduce blood pressure in patients whose baseline systolic blood pressure is 110 or more; the investigators will also examine whether the reduction in blood pressure with treatment is proportional to the increase in the circulating vitamin level with treatment.

Official Title
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Vitamin Deficiency and Blood Pressure in Hospitalized JGH Patients

Conditions
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Vitamin C Deficiency, Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: Vitamin D
* Dietary Supplement: Vitamin C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Competent to grant informed consent Anticipated to remain in hospital at least 7 days after enrollment Exclusion Criteria: End-stage renal disease on renal replacement therapy Critical illness Judged unstable clinical status at the time of enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: vitamin C compared with vitamin D in prospective clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D<br>1000 IU twice daily for up to 10 days | Dietary Supplement: Vitamin D<br>* 1000 IU twice daily for up to 10 days<br>Dietary Supplement: Vitamin C<br>* 500 mg twice daily for up to 10 days<br>|
| Active Comparator: Vitamin C<br>500 mg twice daily for up to 10 days | Dietary Supplement: Vitamin C<br>* 500 mg twice daily for up to 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure |  | every 2 days for up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma vitamin levels: monitoring variable |  | at beginning and end of treatment course | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood pressure, Vitamin C, Vitamin D