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

Vitamin Deficiency and Blood Pressure in Hospitalized JGH Patients

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Vitamin C Deficiency
• Intervention / Treatment: Dietary supplement: Vitamin D; Dietary supplement: Vitamin C

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jewish General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: June 15, 2009
• First Submitted That Met QC Criteria: June 15, 2009
• First Posted (Estimate): June 16, 2009

Study Record Updates

• Last Update Posted (Actual): August 18, 2017
• Last Update Submitted That Met QC Criteria: August 15, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Vitamin D; Blood pressure; Vitamin C
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Nutrition Disorders; Hemorrhagic Disorders; Hemostatic Disorders; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Avitaminosis; Scurvy; Ascorbic Acid Deficiency; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Bone Density Conservation Agents; Antioxidants; Vitamin D; Vitamins; Ascorbic Acid
• Other Study ID Numbers: 09-041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No