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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Hoffer, Jewish General Hospital
ClinicalTrials.gov Identifier:
NCT00921622
First received: June 15, 2009
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Vitamin C Deficiency
Vitamin D Deficiency
Dietary Supplement: Vitamin D
Dietary Supplement: Vitamin C
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin Deficiency and Blood Pressure in Hospitalized JGH Patients

Resource links provided by NLM:


Further study details as provided by Jewish General Hospital:

Primary Outcome Measures:
  • blood pressure [ Time Frame: every 2 days for up to 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • plasma vitamin levels: monitoring variable [ Time Frame: at beginning and end of treatment course ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: June 2009
Study Completion Date: June 2011
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00921622

Locations
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Jewish General Hospital
  More Information

Publications:
Responsible Party: John Hoffer, Physician, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT00921622     History of Changes
Other Study ID Numbers: 09-041
Study First Received: June 15, 2009
Last Updated: June 20, 2013
Health Authority: Canada: Health Canada

Keywords provided by Jewish General Hospital:
Blood pressure
Vitamin C
Vitamin D

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Ascorbic Acid Deficiency
Scurvy
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Vitamin D
Ergocalciferols
Vitamins
Ascorbic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on September 18, 2014