Patients With Hypovitaminosis C and D Clinical Trial
Official title:
Vitamin Therapy in JGH Patients
| Verified date | February 2018 |
| Source | Jewish General Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
There is a high prevalence of hypovitaminosis C and D in our hospital and other acute-care
hospitals. Since the correction of these presumed deficiency states is simple, safe and
inexpensive, their documented or suspected presence would normally be considered sufficient
indication to correct them. However, the common practice is to ignore them. Identification of
specific measurable medical consequences of hypovitaminosis C or D would provide a stronger
case to treat or prevent in-hospital vitamin deficiency states.
Biochemical deficiencies of vitamin C and D have both been linked to mood disturbance, and
hypovitaminosis C reportedly increases blood histamine concentrations.
We recently found that the provision of vitamin C (500 mg twice daily) but not vitamin D
(1000 IU twice daily) promptly improved the average mood score of acutely hospitalized
patients. We will now conduct a closely similar randomized clinical trial using a more
adequate dose of vitamin D, namely 5000 IU/day for up to 10 days.
| Status | Completed |
| Enrollment | 88 |
| Est. completion date | September 2011 |
| Est. primary completion date | September 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - acutely hospitalized in our hospital - mentally competent - judged likely to remain in hospital for at least the following 7 days - fluent in French or English Exclusion Criteria: - presence of hypercalcemia - receiving hemodialysis treatment - critically ill - unable to take medication by mouth |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Jewish General Hospital | Montreal | Quebec |
| Lead Sponsor | Collaborator |
|---|---|
| Jewish General Hospital | McGill University |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | mood | total mood disturbance score on the POMS-B (profile of mood states). Durations of hospital stay are variable and often unpredictable. The intended duration of therapy is 7 to 10 days of treatment, with baseline just prior to starting and outcome measurement recorded just after the final day of therapy. The 7-10 day window is necessary and valid to account for vagaries in duration of hospital stay as well as the interfering effect of weekends when less staffing is available. As in our prior published work, any treatment duration 5 days or longer is included as sufficient. | prior to and after 5-10 days of treatment | |
| Secondary | Blood histamine concentration | Blood histamine concentration. Durations of hospital stay are variable and often unpredictable. The intended duration of therapy is 7 to 10 days of treatment, with baseline just prior to starting and outcome measurement recorded just after the final day of therapy. The 7-10 day window is necessary and valid to account for vagaries in duration of hospital stay as well as the interfering effect of weekends when less staffing is available. As in our prior published work, any treatment duration 5 days or longer is included as sufficient. | prior to and after 5-10 days of treatment | |
| Secondary | distress | the distress thermometer. Durations of hospital stay are variable and often unpredictable. The intended duration of therapy is 7 to 10 days of treatment, with baseline just prior to starting and outcome measurement recorded just after the final day of therapy. The 7-10 day window is necessary and valid to account for vagaries in duration of hospital stay as well as the interfering effect of weekends when less staffing is available. As in our prior published work, any treatment duration 5 days or longer is included as sufficient. | prior to and after 5-10 days of treatment |