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Vitamin Therapy in JGH Patients

Primary Purpose

Patients With Hypovitaminosis C and D, Vitamin Deficiencies

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
vitamin C or vitamin D
Sponsored by
Jewish General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Hypovitaminosis C and D focused on measuring ascorbic acid, cholecalciferol, vitamin C, vitamin D, hypovitaminosis, mood, distress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jewish General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

vitamin C

vitamin D

Arm Description

vitamin C 500 mg twice daily

vitamin D 5000 IU daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 21, 2011
Last Updated
February 28, 2018
Sponsor
Jewish General Hospital
Collaborators
McGill University
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1. Study Identification

Unique Protocol Identification Number
NCT01630720
Brief Title
Vitamin Therapy in JGH Patients
Official Title
Vitamin Therapy in JGH Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jewish General Hospital
Collaborators
McGill University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
HYPOTHESIS: Adequate vitamin C or vitamin D provision to mentally competent acutely hospitalized patients for 7 to 10 days will correct their biochemical deficiency, improve their mood, and (in the vitamin C-treated patients) reduce blood histamine concentrations. PROTOCOL: Mentally competent patients fluent in English or French admitted to the surgical or medical units of the hospital will be offered participation. Plasma vitamin C and 25-hydroxyvitamin D, serum C-reactive protein, parathyroid hormone level (a measure of vitamin D adequacy) and blood histamine will be measured in participating patients prior to starting the treatment and after 7 to 10 days of treatment. Within 24 h prior to and within 24 after the 5-10 d treatment course the patient will complete the POMS-B, a validated one-page 30-item questionnaire that assesses mood and energy, and the Distress Thermometer. Patients followed only for the 5-10 d duration of the clinical trial. The chart will be reviewed for age, sex, diagnosis, and pertinent lab results. After the initial blood sample has been drawn and the questionnaire completed the patient will begin treatment either with vitamin C 500 mg twice daily or vitamin D 5000 IU daily; both vitamins will be prescribed by one of the collaborating physicians without knowledge of the person who recruits, assesses and follows the patient. Treatment assignment will be by coin toss. 7. The questionnaire and blood sampling will be repeated after 7 to 10 days of treatment (as determined by feasibility and the situation on the ward) or prior to discharge if discharge is going to occur before the full course of treatment. 8. Neither the patient nor the person who administers the questionnaires will know which patient receives vitamin C or D. The vitamin D and C tablets are distinguishable, so patients motivated to do so could figure out which vitamin they are being prescribed. Since both treatments are being used to correct deficiency diseases which are strongly suspected to affect mood, neither patients, nurses, nor the students following the patients have no basis to anticipate that one treatment will improve their mood more than the other one.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Hypovitaminosis C and D, Vitamin Deficiencies
Keywords
ascorbic acid, cholecalciferol, vitamin C, vitamin D, hypovitaminosis, mood, distress

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vitamin C
Arm Type
Active Comparator
Arm Description
vitamin C 500 mg twice daily
Arm Title
vitamin D
Arm Type
Active Comparator
Arm Description
vitamin D 5000 IU daily
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin C or vitamin D
Intervention Description
vitamin C 500 mg twice daily versus vitamin D 5000 IU daily for 7 to 10 days
Primary Outcome Measure Information:
Title
mood
Description
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.
Time Frame
prior to and after 5-10 days of treatment
Secondary Outcome Measure Information:
Title
Blood histamine concentration
Description
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.
Time Frame
prior to and after 5-10 days of treatment
Title
distress
Description
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.
Time Frame
prior to and after 5-10 days of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23885048
Citation
Wang Y, Liu XJ, Robitaille L, Eintracht S, MacNamara E, Hoffer LJ. Effects of vitamin C and vitamin D administration on mood and distress in acutely hospitalized patients. Am J Clin Nutr. 2013 Sep;98(3):705-11. doi: 10.3945/ajcn.112.056366. Epub 2013 Jul 24.
Results Reference
derived

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Vitamin Therapy in JGH Patients

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