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

NCT ID: NCT00921622

Last Updated: 2017-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Vitamin C Deficiency Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

vitamin C compared with vitamin D in prospective clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vitamin D

1000 IU twice daily for up to 10 days

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

1000 IU twice daily for up to 10 days

Vitamin C

Intervention Type DIETARY_SUPPLEMENT

500 mg twice daily for up to 10 days

Vitamin C

500 mg twice daily for up to 10 days

Group Type ACTIVE_COMPARATOR

Vitamin C

Intervention Type DIETARY_SUPPLEMENT

500 mg twice daily for up to 10 days

Interventions

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Vitamin D

1000 IU twice daily for up to 10 days

Intervention Type DIETARY_SUPPLEMENT

Vitamin C

500 mg twice daily for up to 10 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jewish General Hospital

OTHER

Sponsor Role lead

Responsible Party

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John Hoffer

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jewish General Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 18838532 (View on PubMed)

Other Identifiers

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09-041

Identifier Type: -

Identifier Source: org_study_id

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