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

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. Read our disclaimer for details. Identifier: NCT00921622
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : August 18, 2017
Information provided by (Responsible Party):
John Hoffer, Jewish General Hospital

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.

Condition or disease Intervention/treatment Phase
Vitamin C Deficiency Vitamin D Deficiency Dietary Supplement: Vitamin D Dietary Supplement: Vitamin C Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: vitamin C compared with vitamin D in prospective clinical trial
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin Deficiency and Blood Pressure in Hospitalized JGH Patients
Study Start Date : June 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : June 2011

Arm Intervention/treatment
Active Comparator: Vitamin D
1000 IU twice daily for up to 10 days
Dietary Supplement: Vitamin D
1000 IU twice daily for up to 10 days

Dietary Supplement: Vitamin C
500 mg twice daily for up to 10 days

Active Comparator: Vitamin C
500 mg twice daily for up to 10 days
Dietary Supplement: Vitamin C
500 mg twice daily for up to 10 days

Primary Outcome Measures :
  1. blood pressure [ Time Frame: every 2 days for up to 10 days ]

Secondary Outcome Measures :
  1. plasma vitamin levels: monitoring variable [ Time Frame: at beginning and end of treatment course ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00921622

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Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Jewish General Hospital
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Responsible Party: John Hoffer, Physician, Jewish General Hospital Identifier: NCT00921622    
Other Study ID Numbers: 09-041
First Posted: June 16, 2009    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by John Hoffer, Jewish General Hospital:
Blood pressure
Vitamin C
Vitamin D
Additional relevant MeSH terms:
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Vitamin D Deficiency
Ascorbic Acid Deficiency
Deficiency Diseases
Nutrition Disorders
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Vitamin D
Ascorbic Acid
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents