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NCT Number: NCT00921622

Vitamin Deficiency and Blood Pressure in Hospitalized Jewish General Hospital (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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Dietary Supplement

1000 IU twice daily for up to 10 days

Vitamin C

Dietary Supplement

500 mg twice daily for up to 10 days

Primary outcomes

  1. blood pressure

    Time frame: every 2 days for up to 10 days

Secondary outcomes

  1. plasma vitamin levels: monitoring variable

    Time frame: at beginning and end of treatment course

Sponsors and collaborators

Lead sponsor

Jewish General Hospital

Other

Registry information

Official study title

Vitamin Deficiency and Blood Pressure in Hospitalized JGH Patients

Important dates

Study start
2009
Primary completion
2009
Study completion
2011
First posted
Jun 16, 2009
Registry last updated
Aug 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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