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

NCT00921622 | Completed Phase 2

• 1 other identifier: 09-041
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin C Deficiency; Vitamin D Deficiency

Keywords

Blood pressure; Vitamin C; Vitamin D

Outcome Measures

Primary Outcomes (1)

• blood pressure

  every 2 days for up to 10 days

Secondary Outcomes (1)

• plasma vitamin levels: monitoring variable

  at beginning and end of treatment course

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

1000 IU twice daily for up to 10 days

Dietary Supplement: Vitamin D; Dietary Supplement: Vitamin C

Vitamin C

ACTIVE COMPARATOR

500 mg twice daily for up to 10 days

Dietary Supplement: Vitamin C

Interventions

Vitamin D DIETARY_SUPPLEMENT

1000 IU twice daily for up to 10 days

Vitamin D

Vitamin C DIETARY_SUPPLEMENT

500 mg twice daily for up to 10 days

Vitamin C; Vitamin D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Competent to grant informed consent
• Anticipated to remain in hospital at least 7 days after enrollment

You may not qualify if:

• End-stage renal disease on renal replacement therapy
• Critical illness
• Judged unstable clinical status at the time of enrollment

Sponsors & Collaborators

• Jewish General Hospital: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (1)

• 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.

  PMID: 18838532 BACKGROUND

MeSH Terms

Conditions

Ascorbic Acid Deficiency; Vitamin D Deficiency

Interventions

Vitamin D; Ascorbic Acid

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: vitamin C compared with vitamin D in prospective clinical trial

Study Record Dates

• First Submitted: June 15, 2009
• First Posted: June 16, 2009
• Study Start: June 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: June 1, 2011
• Last Updated: August 18, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)