Vitamin Deficiency and Blood Pressure in Hospitalized Jewish General Hospital (JGH) Patients
Primary Purpose
Vitamin C Deficiency, Vitamin D Deficiency
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Vitamin D
Vitamin C
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin C Deficiency focused on measuring Blood pressure, Vitamin C, Vitamin D
Eligibility Criteria
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
Sites / Locations
- Jewish General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Vitamin D
Vitamin C
Arm Description
1000 IU twice daily for up to 10 days
500 mg twice daily for up to 10 days
Outcomes
Primary Outcome Measures
blood pressure
Secondary Outcome Measures
plasma vitamin levels: monitoring variable
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00921622
Brief Title
Vitamin Deficiency and Blood Pressure in Hospitalized Jewish General Hospital (JGH) Patients
Official Title
Vitamin Deficiency and Blood Pressure in Hospitalized JGH Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jewish General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin C Deficiency, Vitamin D Deficiency
Keywords
Blood pressure, Vitamin C, Vitamin D
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
vitamin C compared with vitamin D in prospective clinical trial
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Description
1000 IU twice daily for up to 10 days
Arm Title
Vitamin C
Arm Type
Active Comparator
Arm Description
500 mg twice daily for up to 10 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
1000 IU twice daily for up to 10 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C
Intervention Description
500 mg twice daily for up to 10 days
Primary Outcome Measure Information:
Title
blood pressure
Time Frame
every 2 days for up to 10 days
Secondary Outcome Measure Information:
Title
plasma vitamin levels: monitoring variable
Time Frame
at beginning and end of treatment course
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18838532
Citation
Gan R, Eintracht S, Hoffer LJ. Vitamin C deficiency in a university teaching hospital. J Am Coll Nutr. 2008 Jun;27(3):428-33. doi: 10.1080/07315724.2008.10719721.
Results Reference
background
Learn more about this trial
Vitamin Deficiency and Blood Pressure in Hospitalized Jewish General Hospital (JGH) Patients
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