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

Vitamin D Deficiency Clinical Trial

Official title:

Vitamin Deficiency and Blood Pressure in Hospitalized JGH Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921622
• Other study ID #: 09-041
• Status: Completed
• Phase: Phase 2
• First received: June 15, 2009
• Last updated: August 15, 2017
• Start date: June 2009
• Est. completion date: June 2011

Study information

• Verified date: August 2017
• Source: Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2011
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ascorbic Acid Deficiency
• Avitaminosis
• Scurvy
• Vitamin C Deficiency
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D
1000 IU twice daily for up to 10 days
• Vitamin C
500 mg twice daily for up to 10 days

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Jewish General Hospital

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure		every 2 days for up to 10 days
Secondary	plasma vitamin levels: monitoring variable		at beginning and end of treatment course